Glaucoma, Angle-ClosureNCT02964676
Clinical Efficacy and Safety of Minimally Invasive Glaucoma Surgery on Primary Angle Closure Glaucoma
A study testing ab interno trabeculectomy with Trabectome and trabeculectomy in people with Glaucoma, Angle-Closure, run by Shanghai Eye Disease Prevention and Treatment Center.
Trial summary
To evaluate the clinical efficacy (intraocular pressure reduction , success rate, the number of antiglaucoma medication) and safety of ab interno trabeculectomy (AIT) with Trabectome in Chinese PACG . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Angle-Closure
- What is being tested?
- ab interno trabeculectomy with Trabectome and trabeculectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Angle Closure Glaucoma (PACG) with visible trabecular meshwork from 90︒ to 180︒ on gonioscopy and IOP couldn't be controlled ≤21mmHg with pilocarpine eye drop only.
- willing to accept the antiglaucoma surgery
- volunteer to participate in this study and be able to follow up on time
- previous antiglaucoma filtering surgery or laser surgery(LPI, SLT) and previous cataract surgery were not ruled out
Who cannot join
- visual acuity lower than HM or central tubular visual field
- corneal edema or large pterygium affecting the observation of anterior angle
- the demarcation of the scleral process and trabecular meshwork is not clear on gonioscopy
- new vessels on the iris surface or in the anterior angle chamber
- the eye received surgery is the only eye with visual function, that is the contralateral eye is blind
- requiring long-term use of anticoagulant drugs for systemic reasons
Show all 9Show fewer
- abnormal coagulation function
- with specific clear scar physique
- cannot participate in follow-up
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Efficacy and Safety of Minimally Invasive Glaucoma Surgery on Chinese Primary Angle Closure Glaucoma
To evaluate the clinical efficacy (intraocular pressure reduction , success rate, the number of antiglaucoma medication) and safety of ab interno trabeculectomy (AIT) with Trabectome in Chinese PACG .
Read the detailed description
A randomized, single blind, positive parallel control study method was used.This prospective case series will recruit 246 Chinese POAG, 123 cases in the experimental group will receive AIT treatment and 123 cases in the control group will receive trabeculectomy(Trab) surgery.Measurements of intraocular pressure(IOP) , visual acuity, refraction, slit lamp examination of the anterior segment and fundus, optical coherence tomography(OCT) to detect retinal nerve fiber layer thickness, macular thickness, visual field, gonioscopy and ultrasonic biological microscopy (UBM) will be recorded.They will be followed up for 12 months. The main outcome is success rate of IOP reduction and the other outcome are the number of antiglaucoma medication and complications .
- Conditions
- Glaucoma, Angle-Closure
- Being tested
- ab interno trabeculectomy with Trabectome, trabeculectomy
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ab interno trabeculectomy with TrabectomeProcedure or surgery
123 PACG will be recruited to receive ab interno trabeculectomy with Trabectome and before this surgery, laser peripheral iridectomy will be performed firstly
trabeculectomyProcedure or surgery
123 PACG will be recruited to receive trabeculectomy to reduce IOP
| Study group | Role | What they receive |
|---|---|---|
| AIT group | Experimental | PACG in AIT group will receive ab interno trabeculectomy with Trabectome and before AIT, Laser Peripheral Iridectomy (LPI) will be performed first. Receives: Procedure: ab interno trabeculectomy with Trabectome |
| Trab group | Active comparator | PACG in AIT group will receive trabeculectomy. Receives: Procedure: trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of IOP reduction
IOP ≤21mmHg and IOP reduction rate ≥20% with or without antiglaucoma medications and without additional glaucoma surgery
Measured: 12 months
Secondary outcomes (3)
number of antiglaucoma medication
numbers of antiglaucoma medication will be recorded before surgery and 12 months follow up.
Measured: 12 months
complication rate
all the complications related to the surgery will be evaluated and recorded.
Measured: 12 months
24-hour IOP fluctuations
24-hour IOP fluctuations curve will be recorded before treatment and 12 months follow up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Angle-ClosureStudies 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
- Investigator
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LING GE, M.d., Principal investigator, Shanghai Eye Disease Prevention and Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964676
- Sponsor's protocol ID
- YFZX2016002
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
He M, Foster PJ, Ge J, Huang W, Zheng Y, Friedman DS, Lee PS, Khaw PT. Prevalence and clinical characteristics of glaucoma in adult Chinese: a population-based study in Liwan District, Guangzhou. Invest Ophthalmol Vis Sci. 2006 Jul;47(7):2782-8. doi: 10.1167/iovs.06-0051.
PubMed 16799014Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.
PubMed 12049574Palanca-Capistrano AM, Hall J, Cantor LB, Morgan L, Hoop J, WuDunn D. Long-term outcomes of intraoperative 5-fluorouracil versus intraoperative mitomycin C in primary trabeculectomy surgery. Ophthalmology. 2009 Feb;116(2):185-90. doi: 10.1016/j.ophtha.2008.08.009. Epub 2008 Oct 18.
PubMed 18930550Wang M, Fang M, Bai YJ, Zhang WZ, Lin MK, Liu BQ, Hao YT, Ling YL, Zhuo YH, Ge J. Comparison of combined phacotrabeculectomy with trabeculectomy only in the treatment of primary angle-closure glaucoma. Chin Med J (Engl). 2012 Apr;125(8):1429-33.
PubMed 22613648Wagn X, Jia C, Feng MY, Meng HL, Fan SJ, Xie LL, Sun LP, Liu LR, Xie C, Peng Y, Tang X, Liagn YB, Zhai G, Jiang YQ, Ye TC, Wang NL. [Assess correlation between bleb morphology at long-term intraocular pressure effect in primary angle-closure glaucoma following trabeculectomy]. Zhonghua Yan Ke Za Zhi. 2011 Oct;47(10):898-902. Chinese.
PubMed 22321499Wang M, Ge J, Lin MK, Zhuo YH, Ling YL, Fang M, Liu X, Peng SX, Yu MB. [Clinical observation of trabeculectomy for primary angle closure glaucoma]. Zhonghua Yan Ke Za Zhi. 2009 Apr;45(4):338-43. Chinese.
PubMed 19575967Sihota R, Gupta V, Agarwal HC. Long-term evaluation of trabeculectomy in primary open angle glaucoma and chronic primary angle closure glaucoma in an Asian population. Clin Exp Ophthalmol. 2004 Feb;32(1):23-8. doi: 10.1046/j.1442-9071.2004.00752.x.
PubMed 14746586Tsai HY, Liu CJ, Cheng CY. Combined trabeculectomy and cataract extraction versus trabeculectomy alone in primary angle-closure glaucoma. Br J Ophthalmol. 2009 Jul;93(7):943-8. doi: 10.1136/bjo.2008.151803. Epub 2009 Apr 20.
PubMed 19383599Wilson MR, Mendis U, Paliwal A, Haynatzka V. Long-term follow-up of primary glaucoma surgery with Ahmed glaucoma valve implant versus trabeculectomy. Am J Ophthalmol. 2003 Sep;136(3):464-70. doi: 10.1016/s0002-9394(03)00239-3.
PubMed 12967799Soltau JB, Rothman RF, Budenz DL, Greenfield DS, Feuer W, Liebmann JM, Ritch R. Risk factors for glaucoma filtering bleb infections. Arch Ophthalmol. 2000 Mar;118(3):338-42. doi: 10.1001/archopht.118.3.338.
PubMed 10721955DeBry PW, Perkins TW, Heatley G, Kaufman P, Brumback LC. Incidence of late-onset bleb-related complications following trabeculectomy with mitomycin. Arch Ophthalmol. 2002 Mar;120(3):297-300. doi: 10.1001/archopht.120.3.297.
PubMed 11879132Saheb H, Ahmed II. Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol. 2012 Mar;23(2):96-104. doi: 10.1097/ICU.0b013e32834ff1e7.
PubMed 22249233Ho CL, Lai JS, Aquino MV, Rojanapongpun P, Wong HT, Aquino MC, Gerber Y, Belkin M, Barkana Y. Selective laser trabeculoplasty for primary angle closure with persistently elevated intraocular pressure after iridotomy. J Glaucoma. 2009 Sep;18(7):563-6. doi: 10.1097/IJG.0b013e318193c2d1.
PubMed 19745672Mosaed S, Dustin L, Minckler DS. Comparative outcomes between newer and older surgeries for glaucoma. Trans Am Ophthalmol Soc. 2009 Dec;107:127-33.
PubMed 20126489Minckler D, Mosaed S, Dustin L, Ms BF; Trabectome Study Group. Trabectome (trabeculectomy-internal approach): additional experience and extended follow-up. Trans Am Ophthalmol Soc. 2008;106:149-59; discussion 159-60.
PubMed 19277230
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Minimally Invasive Glaucoma Surgery on Chinese Primary Angle Closure Glaucoma
- ClinicalTrials.gov ID
- NCT02964676
- Acronym / sponsor ID
- YFZX2016002
- Conditions
- Glaucoma, Angle-Closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the clinical efficacy (intraocular pressure reduction , success rate, the number of antiglaucoma medication) and safety of ab interno trabeculectomy (AIT) with Trabectome in Chinese PACG .
Detailed description
A randomized, single blind, positive parallel control study method was used.This prospective case series will recruit 246 Chinese POAG, 123 cases in the experimental group will receive AIT treatment and 123 cases in the control group will receive trabeculectomy(Trab) surgery.Measurements of intraocular pressure(IOP) , visual acuity, refraction, slit lamp examination of the anterior segment and fundus, optical coherence tomography(OCT) to detect retinal nerve fiber layer thickness, macular thickness, visual field, gonioscopy and ultrasonic biological microscopy (UBM) will be recorded.They will be followed up for 12 months. The main outcome is success rate of IOP reduction and the other outcome are the number of antiglaucoma medication and complications .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIT group | Experimental | Procedure: ab interno trabeculectomy with TrabectomePACG in AIT group will receive ab interno trabeculectomy with Trabectome and before AIT, Laser Peripheral Iridectomy (LPI) will be performed first. |
| Trab group | Active comparator | Procedure: trabeculectomyPACG in AIT group will receive trabeculectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary Angle Closure Glaucoma (PACG) with visible trabecular meshwork from 90︒ to 180︒ on gonioscopy and IOP couldn't be controlled ≤21mmHg with pilocarpine eye drop only.
- willing to accept the antiglaucoma surgery
- volunteer to participate in this study and be able to follow up on time
- previous antiglaucoma filtering surgery or laser surgery(LPI, SLT) and previous cataract surgery were not ruled out
Key exclusion criteria (9 listed)
- visual acuity lower than HM or central tubular visual field
- corneal edema or large pterygium affecting the observation of anterior angle
- the demarcation of the scleral process and trabecular meshwork is not clear on gonioscopy
- new vessels on the iris surface or in the anterior angle chamber
- the eye received surgery is the only eye with visual function, that is the contralateral eye is blind
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 |
|---|---|---|
| ab interno trabeculectomy with Trabectome123 PACG will be recruited to receive ab interno trabeculectomy with Trabectome and before this surgery, laser peripheral iridectomy will be performed firstly | Procedure or surgery | AIT group |
| trabeculectomy123 PACG will be recruited to receive trabeculectomy to reduce IOP | Procedure or surgery | Trab group |
Primary outcome
success rate of IOP reduction
Time frame: 12 months
IOP ≤21mmHg and IOP reduction rate ≥20% with or without antiglaucoma medications and without additional glaucoma surgery
3 secondary outcomes
number of antiglaucoma medication
Time frame: 12 months
complication rate
Time frame: 12 months
24-hour IOP fluctuations
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Background: PubMed 16799014He M, Foster PJ, Ge J, Huang W, Zheng Y, Friedman DS, Lee PS, Khaw PT. Prevalence and clinical characteristics of glaucoma in adult Chinese: a population-based study in Liwan District, Guangzhou. Invest Ophthalmol Vis Sci. 2006 Jul;47(7):2782-8. doi: 10.1167/iovs.06-0051.
- Background: PubMed 12049574Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.
- Background: PubMed 18930550Palanca-Capistrano AM, Hall J, Cantor LB, Morgan L, Hoop J, WuDunn D. Long-term outcomes of intraoperative 5-fluorouracil versus intraoperative mitomycin C in primary trabeculectomy surgery. Ophthalmology. 2009 Feb;116(2):185-90. doi: 10.1016/j.ophtha.2008.08.009. Epub 2008 Oct 18.
- Background: PubMed 22613648Wang M, Fang M, Bai YJ, Zhang WZ, Lin MK, Liu BQ, Hao YT, Ling YL, Zhuo YH, Ge J. Comparison of combined phacotrabeculectomy with trabeculectomy only in the treatment of primary angle-closure glaucoma. Chin Med J (Engl). 2012 Apr;125(8):1429-33.
- Background: PubMed 22321499Wagn X, Jia C, Feng MY, Meng HL, Fan SJ, Xie LL, Sun LP, Liu LR, Xie C, Peng Y, Tang X, Liagn YB, Zhai G, Jiang YQ, Ye TC, Wang NL. [Assess correlation between bleb morphology at long-term intraocular pressure effect in primary angle-closure glaucoma following trabeculectomy]. Zhonghua Yan Ke Za Zhi. 2011 Oct;47(10):898-902. Chinese.
- Background: PubMed 19575967Wang M, Ge J, Lin MK, Zhuo YH, Ling YL, Fang M, Liu X, Peng SX, Yu MB. [Clinical observation of trabeculectomy for primary angle closure glaucoma]. Zhonghua Yan Ke Za Zhi. 2009 Apr;45(4):338-43. Chinese.
- Background: PubMed 14746586Sihota R, Gupta V, Agarwal HC. Long-term evaluation of trabeculectomy in primary open angle glaucoma and chronic primary angle closure glaucoma in an Asian population. Clin Exp Ophthalmol. 2004 Feb;32(1):23-8. doi: 10.1046/j.1442-9071.2004.00752.x.
- Background: PubMed 19383599Tsai HY, Liu CJ, Cheng CY. Combined trabeculectomy and cataract extraction versus trabeculectomy alone in primary angle-closure glaucoma. Br J Ophthalmol. 2009 Jul;93(7):943-8. doi: 10.1136/bjo.2008.151803. Epub 2009 Apr 20.
- Background: PubMed 12967799Wilson MR, Mendis U, Paliwal A, Haynatzka V. Long-term follow-up of primary glaucoma surgery with Ahmed glaucoma valve implant versus trabeculectomy. Am J Ophthalmol. 2003 Sep;136(3):464-70. doi: 10.1016/s0002-9394(03)00239-3.
- Background: PubMed 10721955Soltau JB, Rothman RF, Budenz DL, Greenfield DS, Feuer W, Liebmann JM, Ritch R. Risk factors for glaucoma filtering bleb infections. Arch Ophthalmol. 2000 Mar;118(3):338-42. doi: 10.1001/archopht.118.3.338.
- Background: PubMed 11879132DeBry PW, Perkins TW, Heatley G, Kaufman P, Brumback LC. Incidence of late-onset bleb-related complications following trabeculectomy with mitomycin. Arch Ophthalmol. 2002 Mar;120(3):297-300. doi: 10.1001/archopht.120.3.297.
- Background: PubMed 22249233Saheb H, Ahmed II. Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol. 2012 Mar;23(2):96-104. doi: 10.1097/ICU.0b013e32834ff1e7.
- Individual participant dataSharing planned: Undecided
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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.
LING GE, M.d. principal investigator
Shanghai Eye Disease Prevention and Treatment Center
Questions about this trial
What is this clinical trial studying?
A study testing ab interno trabeculectomy with Trabectome and trabeculectomy in people with Glaucoma, Angle-Closure, run by Shanghai Eye Disease Prevention and Treatment Center.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LING GE, M.d. (+86-21-62717733 ext. 851, geling99@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of IOP reduction (time frame: 12 months). 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 NCT02964676, which also lists 23 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 28 Nov 2016.