NCT07195370

Brief Summary

This study evaluates the effectiveness and safety of YAG laser peripheral iridotomy performed at two different locations (temporal and inferior) in patients with primary angle-closure glaucoma, a leading cause of blindness worldwide. Patients visiting the glaucoma clinic at Feiz Hospital who are candidates for peripheral iridotomy will participate. In each patient, one eye will receive a temporal iridotomy, and the other eye will receive an inferior iridotomy, with patients unaware of the location used in each eye. The study will measure outcomes such as laser power, intraocular pressure, visual symptoms, and complications over six months to determine which approach is more effective and safer.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

August 26, 2025

Last Update Submit

September 19, 2025

Conditions

Keywords

Primary Angle-Closure Glaucoma

Outcome Measures

Primary Outcomes (1)

  • adverse events

    Surgical and postoperative complications (e.g., bleeding, infection, or changes in intraocular pressure).

    1 day, 1 week, 1month

Study Arms (1)

Description: YAG laser peripheral iridotomy performed in the temporal region of one eye. Arm 2 Title

OTHER
Other: peripheral iridotomy

Interventions

This procedure involves using a neodymium-doped yttrium aluminum garnet (YAG) laser to create a small hole in the temporal region of the iris in one eye. It aims to relieve intraocular pressure in patients with primary angle-closure glaucoma by improving the flow of aqueous humor. The procedure is performed under local anesthesia in a clinical setting, with patients unaware of which eye receives this treatment. Outcomes, including laser power, intraocular pressure, visual symptoms, and complications, are monitored over six months.

Description: YAG laser peripheral iridotomy performed in the temporal region of one eye. Arm 2 Title

Eligibility Criteria

Age24 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (typically over 40 years old).
  • Ability to provide informed consent.
  • Narrow or closed anterior chamber angle (based on gonioscopy).
  • Intraocular pressure (IOP) controlled with medication but requiring surgery.
  • No previous iridotomy.

You may not qualify if:

  • Active eye diseases (e.g., infection or inflammation).
  • Advanced cataracts or lens-related issues.
  • Severe visual impairment (e.g., less than 20/200 vision).
  • Uncontrolled systemic diseases (e.g., diabetes or cardiovascular disease).
  • Pregnancy or breastfeeding.
  • Previous eye surgery (except for minor procedures).
  • Inability to follow-up with scheduled visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan University of Medical Sciences

Isfahan, Isfahan, 0098, Iran

Location

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IsfahanUMS

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 26, 2025

Study Start

May 1, 2025

Primary Completion

October 1, 2025

Study Completion

January 1, 2026

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations