GlaucomaNCT02598765
Micro vs. Standard Trabeculectomy Study
A study testing Standard Trabeculectomy and Microtrabeculectomy in people with Glaucoma, run by University of California, San Francisco at 1 site in Nepal.
Trial summary
The purpose of this study is to determine the reduction in intraocular pressure and cumulative incidence of complications between the standard and micro trabeculectomy surgeries 3 months after surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Standard Trabeculectomy and Microtrabeculectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNepal
- Study dates
- 4 Apr 2016to 21 Jul 2020
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 40
- Planning to have a trabeculectomy
Who cannot join
- Life threatening or debilitating disease
- Inability to complete necessary exams and/or ocular disease that would preclude assessment of intraocular pressure, visual field, or optic disc
- Contralateral eye already enrolled in study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the reduction in intraocular pressure and cumulative incidence of complications between the standard and micro trabeculectomy surgeries 3 months after surgery.
Read the detailed description
This study is a randomized, double-masked (study participants and outcome assessors) trial. During the enrollment period, consecutive patients from LEI who are planning to have trabeculectomy surgery and who meet the study enrollment criteria will be randomized to receive standard trabeculectomy or microtrabeculectomy. The primary outcome is complications and change in intraocular pressure after a 3 month follow-up period. We will perform subgroup analyses by stratifying the population according to skin pigmentation to determine whether pigmentation is a predictor of treatment success.
- Conditions
- Glaucoma
- Being tested
- Standard Trabeculectomy, Microtrabeculectomy
- Keywords
- Glaucoma, Trabeculectomy, Eye Disease, Intraocular Pressure, Visual Acuity
- Medical subject headings
- Glaucoma, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TrabeculectomyProcedure or surgery
Fornix-based trabeculectomy with a 3x4 mm scleral flap.
MicrotrabeculectomyProcedure or surgery
Fornix-based trabeculectomy with a 2x2 mm scleral flap.
| Study group | Role | What they receive |
|---|---|---|
| Standard Trabeculectomy | Active comparator | Patients in the Standard Trabeculectomy arm will undergo regular trabeculectomy Receives: Procedure: Standard Trabeculectomy |
| Microtrabeculectomy | Experimental | Patients in the Microtrabeculectomy arm will undergo microtrabeculectomy Receives: Procedure: Microtrabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of complications
Comparison of the cumulative incidence of complications between the treatment groups (regular and micro trabeculectomy) 3 months after surgery
Measured: 3 months after surgery
Secondary outcomes (3)
Reduction in intraocular pressure
Comparison of the reduction in intraocular pressure between the treatment groups (regular and micro trabeculectomy) 3 months after surgery
Measured: 3 months after surgery
Cumulative incidence of complications
Cumulative incidence of complications 6 months and 12 months after surgery will be compared between the treatment groups
Measured: 6 and 12 months after surgery
Reduction of intraocular pressure
Reduction of intraocular pressure 6 months and 12 months after surgery will be compared between the treatment groups
Measured: 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study start4 Apr 2016
- Primary completion21 Jul 2020
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Seva Foundation, Lumbini Eye Institute and Research Centre
- Responsible party
- Sponsor
- Investigators
- Jeremy D Keenan, MD, MPH, Principal investigator, F. I. Proctor Foundation, UCSF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598765
- Sponsor's protocol ID
- 15-16075
- Status last verified
- Apr 2026
- First submitted
- 4 Nov 2015
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro vs. Standard Trabeculectomy Study
- ClinicalTrials.gov ID
- NCT02598765
- Acronym / sponsor ID
- 15-16075
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Trabeculectomy, Eye Disease, Intraocular Pressure, Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Seva Foundation, Lumbini Eye Institute and Research Centre
- Study start
- 4 Apr 2016 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 6 Nov 2015 (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.
The purpose of this study is to determine the reduction in intraocular pressure and cumulative incidence of complications between the standard and micro trabeculectomy surgeries 3 months after surgery.
Detailed description
This study is a randomized, double-masked (study participants and outcome assessors) trial. During the enrollment period, consecutive patients from LEI who are planning to have trabeculectomy surgery and who meet the study enrollment criteria will be randomized to receive standard trabeculectomy or microtrabeculectomy. The primary outcome is complications and change in intraocular pressure after a 3 month follow-up period. We will perform subgroup analyses by stratifying the population according to skin pigmentation to determine whether pigmentation is a predictor of treatment success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Trabeculectomy | Active comparator | Procedure: Standard TrabeculectomyPatients in the Standard Trabeculectomy arm will undergo regular trabeculectomy |
| Microtrabeculectomy | Experimental | Procedure: MicrotrabeculectomyPatients in the Microtrabeculectomy arm will undergo microtrabeculectomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >= 40
- Planning to have a trabeculectomy
Key exclusion criteria (3 listed)
- Life threatening or debilitating disease
- Inability to complete necessary exams and/or ocular disease that would preclude assessment of intraocular pressure, visual field, or optic disc
- Contralateral eye already enrolled in study
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 |
|---|---|---|
| Standard TrabeculectomyFornix-based trabeculectomy with a 3x4 mm scleral flap. | Procedure or surgery | Standard Trabeculectomy |
| MicrotrabeculectomyFornix-based trabeculectomy with a 2x2 mm scleral flap. | Procedure or surgery | Microtrabeculectomy |
Primary outcome
Cumulative incidence of complications
Time frame: 3 months after surgery
Comparison of the cumulative incidence of complications between the treatment groups (regular and micro trabeculectomy) 3 months after surgery
3 secondary outcomes
Reduction in intraocular pressure
Time frame: 3 months after surgery
Cumulative incidence of complications
Time frame: 6 and 12 months after surgery
Reduction of intraocular pressure
Time frame: 6 and 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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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.
Jeremy D Keenan, MD, MPH principal investigator
F. I. Proctor Foundation, UCSF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Trabeculectomy and Microtrabeculectomy in people with Glaucoma, run by University of California, San Francisco at 1 site in Nepal.
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 2 inclusion and 3 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 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumulative incidence of complications (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.