ND-YAG Laser Iris Depigmentation for Cosmoses

Not Applicable

Withdrawn

• Conditions: Iris Depigmentation
• Interventions: Device: Nd-YAG Laser for iris depigmentation

• Registration Number: NCT06099041
• Lead Sponsor: Sohag University

Brief Summary

Nd-YAG Laser for changing iris coloration by the principle of depigmentation for cosmoses Is that procedure safe or not a prospective study

Detailed Description

Nd-YAG Laser for changing iris coloration by the principle of depigmentation for cosmoses Is that procedure safe or not a prospective study safety will be assessed by measuring IOP using Goldman applanation tonometry pre and post-session.

visual acuity assessment in Log-Mar pre and post-session. Refraction assessment pre and post-session. Lens and fundus assessments on slit-lamp and using auxiliary lens 78D

Study Timeline

• Study First Submitted: 2023-09-06
• Study Start: 2023-10-01
• Study First Submitted QC: 2023-10-22
• Study First Posted: 2023-10-25
• Primary Completion: 2024-06
• Study Completion: 2024-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• clear cornea
• clear lens
• normal IOP < 20 mmHg
• adults aged more than 18 years old
• normal fundus
• dark pigmented iris (black or brown)

Exclusion Criteria

• Glaucomatous patients and those receiving anti-glaucoma treatment.
• corneal or lens opacity.
• any fundus abnormality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ND-YAG Laser for iris depigmentation	Nd-YAG Laser for iris depigmentation	ND-YAG Laser for iris depigmentation

Primary Outcome Measures

Name	Time	Method
Monitoring intra-ocular pressure (IOP) by the standard Goldman applanation tonometer before and after ND-YAG Laser for iris depigmentation	one year	Session of Nd-YAG Laser targeting the iris using power less than that used for peripheral iridotomy causing pigment bleaching to change the iris colour for cosmoses, which may cause pigmentary glaucoma (secondary open angle glaucoma).
Safety of ND-YAG Laser, by visual acuity assessment in log-mar subjectively by using Snellen chart before and after ND-YAG Laser	one year	If ND-YAG LASER could affect visual acuity.

Trial Locations

Locations (1)

Elshimaa A.Mateen; 🇪🇬 Sohag, Egypt