GlaucomaASSISTSNCT02691455

The American Glaucoma Society (AGS) Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study (ASSISTS)

A study testing Baerveldt Glaucoma Implant 350-mm2 / BG101-350, Transscleral Diode Laser Cyclophotocoagulation and Ahmed Model FP7 Flexible Plate in people with Glaucoma, run by Robert Feldman at 23 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Outcomes of subjects with uncontrolled glaucoma with a single existing aqueous tube shunt implant undergoing a second aqueous shunt to transscleral diode laser cyclophotocoagulation. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Glaucoma
What is being tested?: Baerveldt Glaucoma Implant 350-mm2 / BG101-350, Transscleral Diode Laser Cyclophotocoagulation and Ahmed Model FP7 Flexible Plate
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 23 sitesUnited States
Study dates: Feb 2016to 30 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Women and men 18 to 85 years of age
Glaucoma not adequately controlled (IOP >18 mmHg on maximum tolerated topical therapy) with a single aqueous shunt (AS).
Best-corrected visual acuity (BCVA) of hand motion (HM) or better in the study eye

Who cannot join

Monocular
Presence of more than one AS in the study eye
Previous cyclodestruction in the study eye
Presence of active iris neovascularization in the study eye
Binocular diplopia
Presence of scleral buckle in the study eye

Show all 16Show fewer

History or scleritis in either eye
History of scleromalacia in the study eye
Insufficient conjunctiva to cover AS in the study eye
IOP cannot be accurately measured with Goldmann applanation, Pneumotonometry, or Tono-Pen in the study eye
Presence of silicone oil in the study eye
Presence of retinal detachment in the study eye
Presence of intraocular or orbital tumor affecting the study eye
Need for cataract extraction or concurrent procedure at the time of study treatment, except tectonic aqueous shunt revisions for both groups is allowed.
In the opinion of the investigator, should not be enrolled in this study
Unwilling or unable to give consent and satisfy requirements of the study

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

New England Eye Center - Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
UNC Kittner Eye Center
Chapel Hill, North Carolina, 27517
University of Virginia Health System
Charlottesville, Virginia, 22903
Glaucoma Consultants of St. Louis
Chesterfield, Missouri, 63017
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, 60611
Robert Cizik Eye Clinic
Houston, Texas, 77030
University of California San Diego - Shiley Eye Institute
La Jolla, California, 92093
University of Southern California
Los Angeles, California, 90033
Bascom Palmer Eye Institute - Miami
Miami, Florida, 33136
WVU Eye Institute
Morgantown, West Virginia, 26506
Vanderbilt Eye Institute
Nashville, Tennessee, 37232
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10003
Edward Harkness Eye Institute / Columbia University Medical Center
New York, New York, 10032
Rutgers; New Jersey Medical School; IOVS
Newark, New Jersey, 07103
Stiles Eyecare Excellence and Glaucoma Institute
Overland Park, Kansas, 66213
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, 33418
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
UPMC Eye Center
Pittsburgh, Pennsylvania, 15213
Devers Eye Institute/Legacy Health
Portland, Oregon, 97210
Virginia Eye Institute
Richmond, Virginia, 23226
Glaucoma Institute of Northern NJ, LLC
Rochelle Park, New Jersey, 07062
University of Washington Medicine Eye Institute
Seattle, Washington, 98104

Other trials in United States

About this study

Official title: The AGS Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study

Outcomes of subjects with uncontrolled glaucoma with a single existing aqueous tube shunt implant undergoing a second aqueous shunt to transscleral diode laser cyclophotocoagulation.

Read the detailed description

This is a study comparing short- (1 year), mid- (3 years), and long-term (5 years) cumulative incidences of failures in participants who undergo a second aqueous shunt (SAS) to those cumulative incidences of failures in participants who undergo a second aqueous shunt (SAS) to those cumulative incidences of failures in participants who undergo transscleral diode laser cyclophotocoagulation (TLC) for eyes with uncontrolled glaucoma with a single existing aqueous tube shunt procedure.

Conditions: Glaucoma
Being tested: Baerveldt Glaucoma Implant 350-mm2 / BG101-350, Transscleral Diode Laser Cyclophotocoagulation, Ahmed Model FP7 Flexible Plate, Baerveldt Glaucoma Implant 250-mm2 / BG103-250
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Baerveldt Glaucoma Implant 350-mm2 / BG101-350Device
Transscleral Diode Laser CyclophotocoagulationProcedure or surgery
Also called Transscleral Diode Laser Cyclophotocoagulation (TLC)
Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
Ahmed Model FP7 Flexible PlateDevice
Baerveldt Glaucoma Implant 250-mm2 / BG103-250Device

Study groups in NCT02691455
Study group	Role	What they receive
Second Aqueous Shunt	Active comparator	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Receives: Device: Baerveldt Glaucoma Implant 350-mm2 / BG101-350; Device: Ahmed Model FP7 Flexible Plate; Device: Baerveldt Glaucoma Implant 250-mm2 / BG103-250
Transscleral Cyclophotocoagulation	Active comparator	Transscleral Diode Laser Cyclophotocoagulation Receives: Procedure: Transscleral Diode Laser Cyclophotocoagulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Eyes That Failed Treatment
Treatment failure is defined as meeting one or more of the following 4 criteria:
1. Intraocular pressure (IOP) a) >18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of < 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or
2. Reoperation for glaucoma; or
3. Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or
4. Loss of light perception vision (NLP).
Measured: from time of intervention to month 6
Number of Eyes That Failed Treatment
Treatment failure is defined as meeting one or more of the following 4 criteria:
1. Intraocular pressure (IOP) a) >18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of < 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or
2. Reoperation for glaucoma; or
3. Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or
4. Loss of light perception vision (NLP).
Measured: from month 6 to month 12
Number of Eyes That Failed Treatment
Treatment failure is defined as meeting one or more of the following 4 criteria:
1. Intraocular pressure (IOP) a) >18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of < 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or
2. Reoperation for glaucoma; or
3. Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or
4. Loss of light perception vision (NLP).
Measured: from month 12 to year 3

Secondary outcomes (39)

Number of Eyes With Vision-threatening Complications
Measured: from the time of intervention to year 3
Number of Eyes That Lost Two or More Lines of Vision as Assessed by the Snellen Chart Visual Acuity Test
The Snellen visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). Loss of lines of vision indicates worsening visual acuity.
Measured: from time of intervention to year 3
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The week 1 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).
Measured: baseline, week 1
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 1 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).
Measured: baseline, month 1
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 3 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).
Measured: baseline, month 3
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 6 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).
Measured: baseline, month 6
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 12 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).
Measured: baseline, month 12
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The year 2 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).
Measured: baseline, year 2
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The year 3 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).
Measured: baseline, year 3
Incidence of Pain
Number of participants who reported pain.
Measured: 1 week
Incidence of Pain
Number of participants who reported pain.
Measured: 1 month
Severity of Pain
Severity of pain was assessed by the Universal Pain Assessment Tool, and the score ranges from 0 to 10, with a higher score indicating greater pain.
Measured: 1 week
Severity of Pain
Severity of pain was assessed by the Universal Pain Assessment Tool, and the score ranges from 0 to 10, with a higher score indicating greater pain.
Measured: 1 month
Number of Office Visits Per Participant From Baseline to 3 Months
Measured: from baseline to 3 months
Number of Office Visits Per Participant Per Month After Month 3
Measured: from month 4 to year 3
Vision-related Quality of Life as Assessed by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 (NEI-VFQ-25) - General Health Subscale
The score on the National Eye Institute (NEI) Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Health Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Vision Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Vision Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Mental Health Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Mental Health Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Distance Activity Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Distance Activity Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Near Activity Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Near Activity Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Peripheral Vision Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Peripheral Vision Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Color Vision Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Color Vision Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Ocular Pain Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Ocular Pain Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Social Functioning Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Social Functioning Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Role Difficulty Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Role Difficulty Subscale
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Measured: month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201630 Sep 2020

First posted25 Feb 2016 (estimated)
Study startFeb 2016
Primary completion30 Sep 2020
Study completion30 Sep 2020

Why it stopped: Difficulty in recruiting participants

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02691455
Sponsor's protocol ID: HSC-MS-15-1053
Acronym: ASSISTS
Status last verified: Oct 2021
First submitted: 15 Feb 2016
Last updated: 2 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: To the American Glaucoma Society members after completion of the study, with an institutional review board (IRB) approved protocol.

Publications

Arora KS, Robin AL, Corcoran KJ, Corcoran SL, Ramulu PY. Use of Various Glaucoma Surgeries and Procedures in Medicare Beneficiaries from 1994 to 2012. Ophthalmology. 2015 Aug;122(8):1615-24. doi: 10.1016/j.ophtha.2015.04.015. Epub 2015 Jun 16.
PubMed 26092196
Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL; Tube versus Trabeculectomy Study Group. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012 May;153(5):789-803.e2. doi: 10.1016/j.ajo.2011.10.026. Epub 2012 Jan 15.
PubMed 22245458
Budenz DL, Barton K, Gedde SJ, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, Buys YM; Ahmed Baerveldt Comparison Study Group. Five-year treatment outcomes in the Ahmed Baerveldt comparison study. Ophthalmology. 2015 Feb;122(2):308-16. doi: 10.1016/j.ophtha.2014.08.043. Epub 2014 Oct 17.
PubMed 25439606
Anand A, Tello C, Sidoti PA, Ritch R, Liebmann JM. Sequential glaucoma implants in refractory glaucoma. Am J Ophthalmol. 2010 Jan;149(1):95-101. doi: 10.1016/j.ajo.2009.07.019. Epub 2009 Oct 17.
PubMed 19837382
Burgoyne JK, WuDunn D, Lakhani V, Cantor LB. Outcomes of sequential tube shunts in complicated glaucoma. Ophthalmology. 2000 Feb;107(2):309-14. doi: 10.1016/s0161-6420(99)00039-1.
PubMed 10690831
Ness PJ, Khaimi MA, Feldman RM, Tabet R, Sarkisian SR Jr, Skuta GL, Chuang AZ, Mankiewicz KA. Intermediate term safety and efficacy of transscleral cyclophotocoagulation after tube shunt failure. J Glaucoma. 2012 Feb;21(2):83-8. doi: 10.1097/IJG.0b013e31820bd1ce.
PubMed 21336148
Jimenez-Roman J, Gil-Carrasco F, Costa VP, Schimiti RB, Lerner F, Santana PR, Vascocellos JP, Castillejos-Chevez A, Turati M, Fabre-Miranda K. Intraocular pressure control after the implantation of a second Ahmed glaucoma valve. Int Ophthalmol. 2016 Jun;36(3):347-53. doi: 10.1007/s10792-015-0125-z. Epub 2015 Sep 3.
PubMed 26334729
Semchyshyn TM, Tsai JC, Joos KM. Supplemental transscleral diode laser cyclophotocoagulation after aqueous shunt placement in refractory glaucoma. Ophthalmology. 2002 Jun;109(6):1078-84. doi: 10.1016/s0161-6420(02)01019-9.
PubMed 12045047
Smith M, Buys YM, Trope GE. Second Ahmed valve insertion in the same eye. J Glaucoma. 2009 Apr-May;18(4):336-40. doi: 10.1097/IJG.0b013e318182edfb.
PubMed 19365202
Godfrey DG, Krishna R, Greenfield DS, Budenz DL, Gedde SJ, Scott IU. Implantation of second glaucoma drainage devices after failure of primary devices. Ophthalmic Surg Lasers. 2002 Jan-Feb;33(1):37-43.
PubMed 11820661
Ko SJ, Hwang YH, Ahn SI, Kim HK. Surgical Outcomes of Additional Ahmed Glaucoma Valve Implantation in Refractory Glaucoma. J Glaucoma. 2016 Jun;25(6):e620-4. doi: 10.1097/IJG.0000000000000298.
PubMed 26091182
Francis BA, Kawji AS, Vo NT, Dustin L, Chopra V. Endoscopic cyclophotocoagulation (ECP) in the management of uncontrolled glaucoma with prior aqueous tube shunt. J Glaucoma. 2011 Oct;20(8):523-7. doi: 10.1097/IJG.0b013e3181f46337.
PubMed 21048513
Sood S, Beck AD. Cyclophotocoagulation versus sequential tube shunt as a secondary intervention following primary tube shunt failure in pediatric glaucoma. J AAPOS. 2009 Aug;13(4):379-83. doi: 10.1016/j.jaapos.2009.05.006.
PubMed 19683190
Schaefer JL, Levine MA, Martorana G, Koenigsman H, Smith MF, Sherwood MB. Failed glaucoma drainage implant: long-term outcomes of a second glaucoma drainage device versus cyclophotocoagulation. Br J Ophthalmol. 2015 Dec;99(12):1718-24. doi: 10.1136/bjophthalmol-2015-306725. Epub 2015 May 29.
PubMed 26024673
Gabelt BT, Kaufman PL. Changes in aqueous humor dynamics with age and glaucoma. Prog Retin Eye Res. 2005 Sep;24(5):612-37. doi: 10.1016/j.preteyeres.2004.10.003.
PubMed 15919228

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The AGS Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study
ClinicalTrials.gov ID: NCT02691455
Acronym / sponsor ID: ASSISTS / HSC-MS-15-1053
Conditions: Glaucoma
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulty in recruiting participants
Enrolment: 50 participants (actual)
Lead sponsor: Robert FeldmanUniversity, hospital or other
Study start: Feb 2016 (actual)
Primary completion: 30 Sep 2020 (actual)
Study completion: 30 Sep 2020 (actual)
First posted: 25 Feb 2016 (estimated)
Results: Posted 14 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Outcomes of subjects with uncontrolled glaucoma with a single existing aqueous tube shunt implant undergoing a second aqueous shunt to transscleral diode laser cyclophotocoagulation.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Second Aqueous Shunt	Active comparator	Device: Baerveldt Glaucoma Implant 350-mm2 / BG101-350, Device: Ahmed Model FP7 Flexible Plate, Device: Baerveldt Glaucoma Implant 250-mm2 / BG103-250Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Transscleral Cyclophotocoagulation	Active comparator	Procedure: Transscleral Diode Laser CyclophotocoagulationTransscleral Diode Laser Cyclophotocoagulation

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Women and men 18 to 85 years of age
Glaucoma not adequately controlled (IOP >18 mmHg on maximum tolerated topical therapy) with a single aqueous shunt (AS).
Best-corrected visual acuity (BCVA) of hand motion (HM) or better in the study eye

Key exclusion criteria (16 listed)

Monocular
Presence of more than one AS in the study eye
Previous cyclodestruction in the study eye
Presence of active iris neovascularization in the study eye
Binocular diplopia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Baerveldt Glaucoma Implant 350-mm2 / BG101-350	Device	Second Aqueous Shunt
Transscleral Diode Laser CyclophotocoagulationAlso: Transscleral Diode Laser Cyclophotocoagulation (TLC)Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.	Procedure or surgery	Transscleral Cyclophotocoagulation
Ahmed Model FP7 Flexible Plate	Device	Second Aqueous Shunt
Baerveldt Glaucoma Implant 250-mm2 / BG103-250	Device	Second Aqueous Shunt

Primary outcome

Number of Eyes That Failed Treatment
Time frame: from time of intervention to month 6
Treatment failure is defined as meeting one or more of the following 4 criteria: 1. Intraocular pressure (IOP) a) >18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of < 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or 2. Reoperation for glaucoma; or 3. Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or 4. Loss of light perception vision (NLP).
Number of Eyes That Failed Treatment
Time frame: from month 6 to month 12
Treatment failure is defined as meeting one or more of the following 4 criteria: 1. Intraocular pressure (IOP) a) >18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of < 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or 2. Reoperation for glaucoma; or 3. Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or 4. Loss of light perception vision (NLP).
Number of Eyes That Failed Treatment
Time frame: from month 12 to year 3
Treatment failure is defined as meeting one or more of the following 4 criteria: 1. Intraocular pressure (IOP) a) >18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of < 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or 2. Reoperation for glaucoma; or 3. Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or 4. Loss of light perception vision (NLP).

39 secondary outcomes

Number of Eyes With Vision-threatening Complications
Time frame: from the time of intervention to year 3
Number of Eyes That Lost Two or More Lines of Vision as Assessed by the Snellen Chart Visual Acuity Test
Time frame: from time of intervention to year 3
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
Time frame: baseline, week 1
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
Time frame: baseline, month 1
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
Time frame: baseline, month 3
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
Time frame: baseline, month 6
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
Time frame: baseline, month 12
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
Time frame: baseline, year 2
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
Time frame: baseline, year 3
Incidence of Pain
Time frame: 1 week
Incidence of Pain
Time frame: 1 month
Severity of Pain
Time frame: 1 week
Severity of Pain
Time frame: 1 month
Number of Office Visits Per Participant From Baseline to 3 Months
Time frame: from baseline to 3 months
Number of Office Visits Per Participant Per Month After Month 3
Time frame: from month 4 to year 3
Vision-related Quality of Life as Assessed by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 (NEI-VFQ-25) - General Health Subscale
Time frame: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Health Subscale
Time frame: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Vision Subscale
Time frame: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Vision Subscale
Time frame: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Mental Health Subscale
Time frame: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Mental Health Subscale
Time frame: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Distance Activity Subscale
Time frame: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Distance Activity Subscale
Time frame: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Near Activity Subscale
Time frame: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Near Activity Subscale
Time frame: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Peripheral Vision Subscale
Time frame: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Peripheral Vision Subscale
Time frame: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Color Vision Subscale
Time frame: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Color Vision Subscale
Time frame: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Ocular Pain Subscale
Time frame: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Ocular Pain Subscale
Time frame: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale
Time frame: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale
Time frame: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale
Time frame: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale
Time frame: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Social Functioning Subscale
Time frame: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Social Functioning Subscale
Time frame: month 12
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Role Difficulty Subscale
Time frame: baseline
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Role Difficulty Subscale
Time frame: month 12

Results and safety

Results posted to the registry on 14 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Second Aqueous Shunt	23	7
Transscleral Cyclophotocoagulation	22	5

Primary outcome: Number of Eyes That Failed Treatment

Time frame: from time of intervention to month 6. Number. Unit: eyes

Measure	Second Aqueous Shunt n = 22	Transscleral Cyclophotocoagulation n = 19
Value	0	0

Population analysed: Only one eye of each participant was eligible for enrollment. Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Primary outcome: Number of Eyes That Failed Treatment

Time frame: from month 6 to month 12. Number. Unit: eyes

Measure	Second Aqueous Shunt n = 18	Transscleral Cyclophotocoagulation n = 19
Value	3	2

Population analysed: Only one eye of each participant was eligible for enrollment. Data for this outcome measure were not collected for 4 in the Second Aqueous Shunt arm and 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Primary outcome: Number of Eyes That Failed Treatment

Time frame: from month 12 to year 3. Number. Unit: eyes

Measure	Second Aqueous Shunt n = 7	Transscleral Cyclophotocoagulation n = 13
Value	0	0

Population analysed: Only one eye of each participant was eligible for enrollment. Only those who did not fail treatment in the previous time period (previous time period is reported in Outcome measure 2) were analyzed in this time period. Data for this outcome measure were not collected for 15 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.

39 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Second Aqueous Shunt	6 of 22 (27.3%)	10 of 22 (45.5%)	3 of 22
Transscleral Cyclophotocoagulation	3 of 20 (15%)	10 of 20 (50%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26092196Arora KS, Robin AL, Corcoran KJ, Corcoran SL, Ramulu PY. Use of Various Glaucoma Surgeries and Procedures in Medicare Beneficiaries from 1994 to 2012. Ophthalmology. 2015 Aug;122(8):1615-24. doi: 10.1016/j.ophtha.2015.04.015. Epub 2015 Jun 16.
Background: PubMed 22245458Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL; Tube versus Trabeculectomy Study Group. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012 May;153(5):789-803.e2. doi: 10.1016/j.ajo.2011.10.026. Epub 2012 Jan 15.
Background: PubMed 25439606Budenz DL, Barton K, Gedde SJ, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, Buys YM; Ahmed Baerveldt Comparison Study Group. Five-year treatment outcomes in the Ahmed Baerveldt comparison study. Ophthalmology. 2015 Feb;122(2):308-16. doi: 10.1016/j.ophtha.2014.08.043. Epub 2014 Oct 17.
Background: PubMed 19837382Anand A, Tello C, Sidoti PA, Ritch R, Liebmann JM. Sequential glaucoma implants in refractory glaucoma. Am J Ophthalmol. 2010 Jan;149(1):95-101. doi: 10.1016/j.ajo.2009.07.019. Epub 2009 Oct 17.
Background: PubMed 10690831Burgoyne JK, WuDunn D, Lakhani V, Cantor LB. Outcomes of sequential tube shunts in complicated glaucoma. Ophthalmology. 2000 Feb;107(2):309-14. doi: 10.1016/s0161-6420(99)00039-1.
Background: PubMed 21336148Ness PJ, Khaimi MA, Feldman RM, Tabet R, Sarkisian SR Jr, Skuta GL, Chuang AZ, Mankiewicz KA. Intermediate term safety and efficacy of transscleral cyclophotocoagulation after tube shunt failure. J Glaucoma. 2012 Feb;21(2):83-8. doi: 10.1097/IJG.0b013e31820bd1ce.
Background: PubMed 26334729Jimenez-Roman J, Gil-Carrasco F, Costa VP, Schimiti RB, Lerner F, Santana PR, Vascocellos JP, Castillejos-Chevez A, Turati M, Fabre-Miranda K. Intraocular pressure control after the implantation of a second Ahmed glaucoma valve. Int Ophthalmol. 2016 Jun;36(3):347-53. doi: 10.1007/s10792-015-0125-z. Epub 2015 Sep 3.
Background: PubMed 12045047Semchyshyn TM, Tsai JC, Joos KM. Supplemental transscleral diode laser cyclophotocoagulation after aqueous shunt placement in refractory glaucoma. Ophthalmology. 2002 Jun;109(6):1078-84. doi: 10.1016/s0161-6420(02)01019-9.
Background: PubMed 19365202Smith M, Buys YM, Trope GE. Second Ahmed valve insertion in the same eye. J Glaucoma. 2009 Apr-May;18(4):336-40. doi: 10.1097/IJG.0b013e318182edfb.
Background: PubMed 11820661Godfrey DG, Krishna R, Greenfield DS, Budenz DL, Gedde SJ, Scott IU. Implantation of second glaucoma drainage devices after failure of primary devices. Ophthalmic Surg Lasers. 2002 Jan-Feb;33(1):37-43.
Background: PubMed 26091182Ko SJ, Hwang YH, Ahn SI, Kim HK. Surgical Outcomes of Additional Ahmed Glaucoma Valve Implantation in Refractory Glaucoma. J Glaucoma. 2016 Jun;25(6):e620-4. doi: 10.1097/IJG.0000000000000298.
Background: PubMed 21048513Francis BA, Kawji AS, Vo NT, Dustin L, Chopra V. Endoscopic cyclophotocoagulation (ECP) in the management of uncontrolled glaucoma with prior aqueous tube shunt. J Glaucoma. 2011 Oct;20(8):523-7. doi: 10.1097/IJG.0b013e3181f46337.
Individual participant dataSharing planned: Yes. To the American Glaucoma Society members after completion of the study, with an institutional review board (IRB) approved protocol.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Feldman, MD study chair

Robert Cizik Eye Clinic

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Eyes That Failed Treatment (time frame: from time of intervention to month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02691455, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.