GlaucomaPhase 4NCT00666237

Primary Tube Versus Trabeculectomy Study

A Phase 4 study testing Tube shunt surgery, Trabeculectomy and Mitomycin C in people with Glaucoma, run by University of Miami at 16 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in eyes that have not had previous ocular surgery. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Glaucoma
What is being tested?: Tube shunt surgery, Trabeculectomy and Mitomycin C
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 242 participants
Where: 16 sitesin 3 countries
Study dates: 1 Apr 2008to 1 Apr 2021
Phase: Phase 4
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

Age 18-85 years
Glaucoma that is inadequately controlled on tolerated medical therapy with Intraocular Pressure (IOP) greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg
No previous incisional ocular surgery

Who cannot join

Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
Pregnant or nursing women
No light perception vision
Active iris neovascularization or active proliferative retinopathy
Iridocorneal endothelial syndrome
Epithelial or fibrous ingrowth

Show all 14Show fewer

Chronic or recurrent uveitis
Steroid-induced glaucoma
Severe posterior blepharitis
Unwilling to discontinue contact lens use after surgery
Previous cyclodestructive procedure
Conjunctival scarring from prior ocular trauma or cicatrizing disease precluding a superior trabeculectomy
Functionally significant cataract
Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery

Trial locations and contacts

16 sites in 3 countries.

Country

City, postcode or hospital

16 sites in 3 countries

United States12 sites

Johns Hopkins
Baltimore, Maryland, 21290
University of Virginia
Charlottesville, Virginia, 22908
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Glaucoma Associates of Texas
Dallas, Texas, 75231
University of Florida
Gainesville, Florida, 32610
University of Texas, Houston
Houston, Texas, 77030
Bascom Palmer Eye Institute
Miami, Florida, 33136
New York Eye and Ear Infirmary
New York, New York, 10003
University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California Davis Medical Center
Sacramento, California, 95817
St. Louis University
St Louis, Missouri, 63104

Other trials in United States

United Kingdom3 sites

Moorfields Eye Hospital
London
St. Thomas' Hospital
London
Queen Mary's Sidcup Hospital
Sidcup

Other trials in United Kingdom

Canada1 site

University of Toronto
Toronto

Other trials in Canada

About this study

Conditions: Glaucoma
Being tested: Tube shunt surgery, Trabeculectomy, Mitomycin C
Keywords: Tube shunt surgery, Trabeculectomy
Medical subject headings: Glaucoma

What participants receive

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

Tube shunt surgeryProcedure or surgery
Also called Baerveldt glaucoma implant
The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
TrabeculectomyProcedure or surgery
The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.
Mitomycin CDrug
A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes

Study groups in NCT00666237
Study group	Role	What they receive
Tube shunt surgery group	Experimental	Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant). Receives: Procedure: Tube shunt surgery
Trabeculectomy with Mitomycin C	Experimental	Participants in this group will receive a Trabeculectomy surgery with Mitomycin C Receives: Procedure: Trabeculectomy; Drug: Mitomycin C

What is being measured

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

Number of Participants With Surgical Failure
Surgical failure is defined as:
1. Inadequate Intraocular Pressure (IOP) Reduction (IOP > 21 mmHg or reduced < 20% below baseline on 2 consecutive follow-up visits after 3 months)
2. Reoperation for glaucoma
3. Persistent hypotony (IOP ≤ 5 mmHg on 2 consecutive visits after 3 months)
4. Loss of light perception vision
Measured: Up to 5 years

Secondary outcomes (7)

Intraocular Pressure
Intraocular pressure will be reported in mmHg and measured using Goldmann applanation tonometry or a Tono-Pen.
Measured: At baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years
Number of Participants With Reported Postoperative Complications
Number of participants with early and late postoperative complications will be reported as per treating physician assessment
Measured: Up to 5 years
Visual Acuity Using a Snellen Chart
Visual acuity will be measured using a Snellen chart on logMAR (Logarithm of Minimal Angle of Resolution) scale. Letter-by letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Measured: At Baseline, At 5 years
Visual Acuity as Measured Using EDTRS Chart
Visual acuity will be reported as the number of correctly identified letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) chart. Total score ranges from 0-100 with the higher score indicating better visual acuity.
Measured: At baseline, At 5 years
Visual Field
Visual fields will be measured using standard automated perimetry.
Measured: Up to 5 years
Reoperation for Glaucoma
The number of participants requiring reoperation for glaucoma will be reported
Measured: Up to 5 years
Number of Glaucoma Medications
The need for supplemental glaucoma medications will be reported as the number of glaucoma medications used
Measured: At Baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years

Timeline

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

1 Apr 20081 Apr 2021

First posted24 Apr 2008 (estimated)
Study start1 Apr 2008
Primary completion1 Apr 2021
Study completion1 Apr 2021

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 (4)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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 242 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00666237
Sponsor's protocol ID: 20071037
Other IDs: EY014801
Status last verified: Oct 2022
First submitted: 23 Apr 2008
Last updated: 19 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Gedde SJ, Chen PP, Heuer DK, Singh K, Wright MM, Feuer WJ, Schiffman JC, Shi W; Primary Tube Versus Trabeculectomy Study Group. The Primary Tube Versus Trabeculectomy Study: Methodology of a Multicenter Randomized Clinical Trial Comparing Tube Shunt Surgery and Trabeculectomy with Mitomycin C. Ophthalmology. 2018 May;125(5):774-781. doi: 10.1016/j.ophtha.2017.10.037. Epub 2017 Dec 18.
PubMed 29248173
Gedde SJ, Feuer WJ, Lim KS, Barton K, Goyal S, Ahmed IIK, Brandt JD; Primary Tube Versus Trabeculectomy Study Group. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up. Ophthalmology. 2020 Mar;127(3):333-345. doi: 10.1016/j.ophtha.2019.10.002. Epub 2019 Oct 9.
PubMed 31727428
Gedde SJ, Feuer WJ, Shi W, Lim KS, Barton K, Goyal S, Ahmed IIK, Brandt J; Primary Tube Versus Trabeculectomy Study Group. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up. Ophthalmology. 2018 May;125(5):650-663. doi: 10.1016/j.ophtha.2018.02.003. Epub 2018 Feb 21.
PubMed 29477688
Gedde SJ, Feuer WJ, Chen PP, Heuer DK, Singh K, Wright MM; Tube Versus Trabeculectomy and Primary Tube Versus Trabeculectomy Study Groups. Comparing Treatment Outcomes from the Tube Versus Trabeculectomy and Primary Tube Versus Trabeculectomy Studies. Ophthalmology. 2021 Feb;128(2):324-326. doi: 10.1016/j.ophtha.2020.06.059. Epub 2020 Jul 2.
PubMed 32622848

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?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Primary Tube Versus Trabeculectomy Study
ClinicalTrials.gov ID: NCT00666237
Acronym / sponsor ID: 20071037
Conditions: Glaucoma
Keywords: Tube shunt surgery, Trabeculectomy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 242 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: Abbott Medical Optics, Research to Prevent Blindness, National Eye Institute (NEI)
Study start: 1 Apr 2008 (actual)
Primary completion: 1 Apr 2021 (actual)
Study completion: 1 Apr 2021 (actual)
First posted: 24 Apr 2008 (estimated)
Results: Posted 19 Oct 2022

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tube shunt surgery group	Experimental	Procedure: Tube shunt surgeryParticipants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
Trabeculectomy with Mitomycin C	Experimental	Procedure: Trabeculectomy, Drug: Mitomycin CParticipants in this group will receive a Trabeculectomy surgery with Mitomycin C

Who may qualify

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

Key inclusion criteria (3 listed)

Age 18-85 years
Glaucoma that is inadequately controlled on tolerated medical therapy with Intraocular Pressure (IOP) greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg
No previous incisional ocular surgery

Key exclusion criteria (14 listed)

Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
Pregnant or nursing women
No light perception vision
Active iris neovascularization or active proliferative retinopathy
Iridocorneal endothelial syndrome

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
Tube shunt surgeryAlso: Baerveldt glaucoma implantThe procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.	Procedure or surgery	Tube shunt surgery group
TrabeculectomyThe procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.	Procedure or surgery	Trabeculectomy with Mitomycin C
Mitomycin CA fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes	Drug	Trabeculectomy with Mitomycin C

Primary outcome

Number of Participants With Surgical Failure
Time frame: Up to 5 years
Surgical failure is defined as: 1. Inadequate Intraocular Pressure (IOP) Reduction (IOP > 21 mmHg or reduced < 20% below baseline on 2 consecutive follow-up visits after 3 months) 2. Reoperation for glaucoma 3. Persistent hypotony (IOP ≤ 5 mmHg on 2 consecutive visits after 3 months) 4. Loss of light perception vision

7 secondary outcomes

Intraocular Pressure
Time frame: At baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years
Number of Participants With Reported Postoperative Complications
Time frame: Up to 5 years
Visual Acuity Using a Snellen Chart
Time frame: At Baseline, At 5 years
Visual Acuity as Measured Using EDTRS Chart
Time frame: At baseline, At 5 years
Visual Field
Time frame: Up to 5 years
Reoperation for Glaucoma
Time frame: Up to 5 years
Number of Glaucoma Medications
Time frame: At Baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years

Results and safety

Results posted to the registry on 19 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tube Shunt Surgery Group	125	91
Trabeculectomy With Mitomycin C	117	87

Primary outcome: Number of Participants With Surgical Failure

Time frame: Up to 5 years. Count of participants. Unit: Participants

Measure	Tube Shunt Surgery Group n = 125	Trabeculectomy With Mitomycin C n = 117
Inadequate IOP reduction	31	23
Reoperation for Glaucoma	18	9
Loss of light perception vision	0	1
Persistent Hypotony	0	5

Population analysed: The number of participants requiring glaucoma operations includes only those that had a failed surgery due to glaucoma reoperation.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tube Shunt Surgery Group	0 of 125 (0%)	51 of 125 (40.8%)	5 of 125
Trabeculectomy With Mitomycin C	0 of 117 (0%)	72 of 117 (61.5%)	5 of 117

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29248173Gedde SJ, Chen PP, Heuer DK, Singh K, Wright MM, Feuer WJ, Schiffman JC, Shi W; Primary Tube Versus Trabeculectomy Study Group. The Primary Tube Versus Trabeculectomy Study: Methodology of a Multicenter Randomized Clinical Trial Comparing Tube Shunt Surgery and Trabeculectomy with Mitomycin C. Ophthalmology. 2018 May;125(5):774-781. doi: 10.1016/j.ophtha.2017.10.037. Epub 2017 Dec 18.
Results publication: PubMed 31727428Gedde SJ, Feuer WJ, Lim KS, Barton K, Goyal S, Ahmed IIK, Brandt JD; Primary Tube Versus Trabeculectomy Study Group. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up. Ophthalmology. 2020 Mar;127(3):333-345. doi: 10.1016/j.ophtha.2019.10.002. Epub 2019 Oct 9.
Results publication: PubMed 29477688Gedde SJ, Feuer WJ, Shi W, Lim KS, Barton K, Goyal S, Ahmed IIK, Brandt J; Primary Tube Versus Trabeculectomy Study Group. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up. Ophthalmology. 2018 May;125(5):650-663. doi: 10.1016/j.ophtha.2018.02.003. Epub 2018 Feb 21.
Results publication: PubMed 32622848Gedde SJ, Feuer WJ, Chen PP, Heuer DK, Singh K, Wright MM; Tube Versus Trabeculectomy and Primary Tube Versus Trabeculectomy Study Groups. Comparing Treatment Outcomes from the Tube Versus Trabeculectomy and Primary Tube Versus Trabeculectomy Studies. Ophthalmology. 2021 Feb;128(2):324-326. doi: 10.1016/j.ophtha.2020.06.059. Epub 2020 Jul 2.
Individual participant dataSharing planned: No

Related trials for Glaucoma

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Not yet recruiting
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Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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RecruitingObservational study
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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.

Steven J Gedde, MD study chair

Bascom Palmer Eye Institute

Dale K Heuer, MD study chair

Medical College of Wisconsin

Richard K Parrish, MD study chair

Bascom Palmer Eye Institute

16 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tube shunt surgery, Trabeculectomy and Mitomycin C in people with Glaucoma, run by University of Miami at 16 sites in 3 countries.

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 14 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: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, United Kingdom, Canada. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2022). 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 Participants With Surgical Failure (time frame: Up to 5 years). 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 NCT00666237, which also lists 4 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 19 Oct 2022.