Iris DepigmentationNCT06099041
ND-YAG Laser Iris Depigmentation for Cosmoses
A study testing Nd-YAG Laser for iris depigmentation in people with Iris Depigmentation, run by Sohag University at 1 site in Egypt.
Trial summary
Nd-YAG Laser for changing iris coloration by the principle of depigmentation for cosmoses Is that procedure safe or not a prospective study Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Iris Depigmentation
- What is being tested?
- Nd-YAG Laser for iris depigmentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- clear cornea
- clear lens
- normal IOP < 20 mmHg
- adults aged more than 18 years old
- normal fundus
- dark pigmented iris (black or brown)
Who cannot join
- Glaucomatous patients and those receiving anti-glaucoma treatment.
- corneal or lens opacity.
- any fundus abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Nd-YAG Laser for changing iris coloration by the principle of depigmentation for cosmoses Is that procedure safe or not a prospective study
Read the 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
- Conditions
- Iris Depigmentation
- Being tested
- Nd-YAG Laser for iris depigmentation
- Keywords
- Nd-YAG Laser, Iris, Cosmoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd-YAG Laser for iris depigmentationDevice
Nd-YAG Laser for iris depigmentation
| Study group | Role | What they receive |
|---|---|---|
| ND-YAG Laser for iris depigmentation | Other | ND-YAG Laser for iris depigmentation Receives: Device: Nd-YAG Laser for iris depigmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring intra-ocular pressure (IOP) by the standard Goldman applanation tonometer before and after ND-YAG Laser for iris depigmentation
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).
Measured: one year
Safety of ND-YAG Laser, by visual acuity assessment in log-mar subjectively by using Snellen chart before and after ND-YAG Laser
If ND-YAG LASER could affect visual acuity.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Oct 2023
- Primary completionJun 2024 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: We found complications, intra ocular pressure elevation and iridocyclitis endangered the patients vision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iris DepigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elshimaa A.Mateen, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099041
- Sponsor's protocol ID
- NILES-EC-CU 23/7/15
- Status last verified
- Apr 2025
- First submitted
- 6 Sep 2023
- Last updated
- 2 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ND-YAG Laser Iris Depigmentation for Cosmoses
- ClinicalTrials.gov ID
- NCT06099041
- Acronym / sponsor ID
- NILES-EC-CU 23/7/15
- Conditions
- Iris Depigmentation
- Keywords
- Nd-YAG Laser, Iris, Cosmoses
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We found complications, intra ocular pressure elevation and iridocyclitis endangered the patients vision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ND-YAG Laser for iris depigmentation | Other | Device: Nd-YAG Laser for iris depigmentationND-YAG Laser for iris depigmentation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- clear cornea
- clear lens
- normal IOP < 20 mmHg
- adults aged more than 18 years old
- normal fundus
Key exclusion criteria (3 listed)
- Glaucomatous patients and those receiving anti-glaucoma treatment.
- corneal or lens opacity.
- any fundus abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nd-YAG Laser for iris depigmentationNd-YAG Laser for iris depigmentation | Device | ND-YAG Laser for iris depigmentation |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nd-YAG Laser for iris depigmentation in people with Iris Depigmentation, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring intra-ocular pressure (IOP) by the standard Goldman applanation tonometer before and after ND-YAG Laser for iris depigmentation (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.