ND-YAG Laser Iris Depigmentation for Cosmoses

• Sponsor: Sohag University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06099041
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Iris Depigmentation	Device: Nd-YAG Laser for iris depigmentation	N/A

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
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: ND-YAG Laser Iris Depigmentation for Cosmoses
• Actual Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: ND-YAG Laser for iris depigmentation ND-YAG Laser for iris depigmentation	Device: Nd-YAG Laser for iris depigmentation; Nd-YAG Laser for iris depigmentation

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Elshimaa A.Mateen	Sohag		Egypt

Sponsors and Collaborators

• Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elshimaa A.Mateen, Clinical professor, Sohag University
• ClinicalTrials.gov Identifier: NCT06099041
• Other Study ID Numbers: NILES-EC-CU 23/7/15
• First Posted: Oct 25, 2023
• Last Update Posted: Oct 25, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Elshimaa A.Mateen, Clinical professor, Sohag University: Nd-YAG Laser, Iris, Cosmoses
• Additional relevant MeSH terms: Hypopigmentation

Study Results

No Results Posted as of Oct 25, 2023