NCT02598765

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

April 4, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2020

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

November 4, 2015

Last Update Submit

April 27, 2026

Conditions

Glaucoma

Keywords

GlaucomaTrabeculectomyEye DiseaseIntraocular PressureVisual Acuity

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of complications

    Comparison of the cumulative incidence of complications between the treatment groups (regular and micro trabeculectomy) 3 months after surgery

    3 months after surgery

Secondary Outcomes (3)

  • Reduction in intraocular pressure

    3 months after surgery

  • Cumulative incidence of complications

    6 and 12 months after surgery

  • Reduction of intraocular pressure

    6 and 12 months after surgery

Study Arms (2)

Standard Trabeculectomy

ACTIVE COMPARATOR

Patients in the Standard Trabeculectomy arm will undergo regular trabeculectomy

Procedure: Standard Trabeculectomy

Microtrabeculectomy

EXPERIMENTAL

Patients in the Microtrabeculectomy arm will undergo microtrabeculectomy

Procedure: Microtrabeculectomy

Interventions

Standard TrabeculectomyPROCEDURE

Fornix-based trabeculectomy with a 3x4 mm scleral flap.

Standard Trabeculectomy
MicrotrabeculectomyPROCEDURE

Fornix-based trabeculectomy with a 2x2 mm scleral flap.

Microtrabeculectomy

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 40
  • Planning to have a trabeculectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lumbini Eye Institute, Nepal

Siddharthanagar, Nepal

Location

MeSH Terms

Conditions

GlaucomaEye Diseases

Condition Hierarchy (Ancestors)

Ocular Hypertension

Study Officials

  • Jeremy D Keenan, MD, MPH

    F. I. Proctor Foundation, UCSF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 6, 2015

Study Start

April 4, 2016

Primary Completion

July 21, 2020

Study Completion

July 21, 2020

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

NE(1)