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Clinical Trials/NCT06099041
NCT06099041WithdrawnNot Applicable

ND-YAG Laser Iris Depigmentation for Cosmoses

Sohag University1 site in 1 country60 target enrollmentStarted: October 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Enrollment
60
Locations
1
Primary Endpoint
Monitoring intra-ocular pressure (IOP) by the standard Goldman applanation tonometer before and after ND-YAG Laser for iris depigmentation

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Monitoring intra-ocular pressure (IOP) by the standard Goldman applanation tonometer before and after ND-YAG Laser for iris depigmentation

Time Frame: 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

Time Frame: one year

If ND-YAG LASER could affect visual acuity.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elshimaa A.Mateen

Clinical professor

Sohag University

Study Sites (1)

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