NCT07591662

Brief Summary

This study aimed to compare between subthreshold diode laser and trabeculotomy in treatment of advanced primary open angle glaucoma throughout 12 months follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 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

Study Start

First participant enrolled

June 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 9, 2026

Last Update Submit

May 9, 2026

Conditions

Subthreshold Diode LaserTrabeculotomyAdvanced Primary Open Angle GlaucomaIntraocular Pressure

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Visual acuity was evaluated using finger counting, hand motion, or light perception

    12 months postoperatively

Secondary Outcomes (2)

  • Intraocular pressure

    12 months postoperatively

  • Degree of pain

    12 months postoperatively

Study Arms (2)

Group A

EXPERIMENTAL

Patients scheduled for subthreshold diode laser.

Procedure: Subthreshold diode laser

Group B

EXPERIMENTAL

Patients scheduled for trabeculotomy.

Procedure: Trabeculotomy

Interventions

Subthreshold diode laserPROCEDURE

Patients scheduled for subthreshold diode laser.

Group A
TrabeculotomyPROCEDURE

Patients scheduled for trabeculotomy.

Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18 years.
  • Open angle glaucoma.
  • Advanced glaucoma (visual field deterioration MD\>-12.00 dB with evidence of optic neuropathy despite maximal therapy).

You may not qualify if:

  • Previous intraocular surgery for glaucoma.
  • Patients who had undergone previous laser therapy for glaucoma.
  • Cases of secondary glaucoma.
  • Media opacity interferes with capturing fundus image.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location

MeSH Terms

Interventions

Trabeculectomy

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Ophthalmology, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.

Study Record Dates

First Submitted

May 9, 2026

First Posted

May 18, 2026

Study Start

June 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations

EG(1)