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A Novel Argon Laser Iridoplasty for Pigment Dispersion Syndrome

Primary Purpose

Pigment Dispersion Syndrome, Pigmentary Glaucoma

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Argon Laser Iridoplasty
Sponsored by
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pigment Dispersion Syndrome

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pigment dispersion syndrome/glaucoma confirmed by either clinical signs or imaging with documented posterior iris bowing.

Exclusion Criteria:

  • Active or history of Uveitis.
  • Pupil size > 7mm in mesopic conditions.
  • Previous Iris-based laser procedures e.g. Iridotomy, Iridoplasty

Sites / Locations

  • Fayoum University HospitalsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Argon Laser Iridoplasty

Arm Description

Argon Laser is applied to the anterior iris surface after pharmacological miosis and instillation of ocular surface anesthetic using YAG capsulotomy lens or Abraham Iridotomy lens as auxiliary lenses. Laser is applied at sites and with parameters that are tailored for each case according to exact iris configuration, iris colour and pupil diameter.

Outcomes

Primary Outcome Measures

correction of posterior iris bowing
The posterior iris bowing is at the basis of pigment dispersion pathology and so the correction of this posterior bowing halts the disease process at its very roots. Correction means either flattening or anterior bowing of iris (a change from negative bowing values to zero bowing or positive bowing values)

Secondary Outcome Measures

Full Information

First Posted
January 30, 2022
Last Updated
July 23, 2022
Sponsor
Fayoum University
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1. Study Identification

Unique Protocol Identification Number
NCT05231928
Brief Title
A Novel Argon Laser Iridoplasty for Pigment Dispersion Syndrome
Official Title
Efficacy of a Novel Argon Laser Iridoplasty for Management of Pigment Dispersion Syndrome Assessed by Anterior Segment Optical Coherence Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pigment dispersion syndrome is a rare condition where anomalous iris configuration leads to posterior iris bowing with subsequent friction with the lenticulozonular unit resulting in dispersion of pigment from the back surface of the iris into the anterior segment as well as thinning with resultant transillumination defects in the mid iris segment. The released pigment is deposited in various parts of the anterior segment resulting in a constellation of clinical signs: Krukenberg Spindle: Back surface of the cornea Zentmayer ring: Back surface of the lens. Egger line: Anterior vitreous face. More importantly, pigment accumulated in the trabecular meshwork leading to visible hyperpigmentation of the trabeculum seen by gonioscopy. This leads to reduction of aqueous outflow which leads to ocular hypertension or even glaucoma which is known as pigment dispersion glaucoma which is considered one of refractory glaucomas. Current practice in the management of pigment dispersion syndrome revolves around the management of glaucoma when it develops by IOP lowering medication, Laser trabeculoplasty or peripheral iridoplastyor glaucoma surgery as a last resort. The only prophylactic measure in practice that is aimed at preventing the progression from mere pigment dispersion to pigment dispersion glaucoma is the long term use of miotic eyedrops e.g. Pilocarpine which comes with both risks and side effects i.e. the risk of retinal breaks and detachment which is even higher in a cohort which is predominantly myope, the constriction of visual field and ocular surface complications. In this interventional case series, the investigators assess the efficacy of a novel Argon Laser iridoplasty in the management of pigment dispersion through correcting the posterior iris bowing and hence halting the dispersion process so that glaucoma wouldn't develop in the first place instead of managing glaucoma after it sets in which proved refractory.
Detailed Description
*Study design: Interventional, longitudinal, prospective, uncontrolled case series study **Methods: Population: cases of pigment dispersion syndrome/glaucoma. Sample size: Not determined since it is a case series with still active recruitment. A series of pigment dispersion syndrome and/or pigment dispersion glaucoma cases encountered in the ophthalmology outpatient clinic of Fayoum University Hospitals will be assessed clinically for confirmation of signs of pigment dispersion by slitlamp examination and gonioscopy. Intraocular pressure will be measured and monitored. Fundus examination with special attention to the optic disc will be done. Cases will be assessed prior to iridoplasty by anterior segment optical coherence tomography to document the anomalous iris configuration with subsequent serial anterior segment OCT at one week, one month and three months after iridoplasty as well as IOP measurement. The iridoplasty procedure will be performed as follows: Pilocarpine 2% topically is used to induce miosis. Topical ocular anesthetic is instilled. The Nidek Argon laser device together with a YAG capsolutomy or Abraham Iridotomy lens as auxilliary lenses are used. The site and parameters of argon laser applications on the anterior iris surface are tailored for each patient according to iris configuration and pupil diameter in mesopic conditions determined by anterior segment OCT. Topical Brimonidine 0.2% bid is used for one week after the procedure to guard against IOP spikes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pigment Dispersion Syndrome, Pigmentary Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Interventional, longitudinal, prospective, uncontrolled case series
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Argon Laser Iridoplasty
Arm Type
Experimental
Arm Description
Argon Laser is applied to the anterior iris surface after pharmacological miosis and instillation of ocular surface anesthetic using YAG capsulotomy lens or Abraham Iridotomy lens as auxiliary lenses. Laser is applied at sites and with parameters that are tailored for each case according to exact iris configuration, iris colour and pupil diameter.
Intervention Type
Procedure
Intervention Name(s)
Argon Laser Iridoplasty
Intervention Description
Argon Laser is applied to the anterior iris surface at sites and with parameters tailored according to iris configuration, pupil size, iris colour. The device used is Nidek Argon Laser device with YAG capsulotomy or Abraham Iridotomy lens as auxilliary lenses. -Topical Pilocarpine 2% and ocular surface anesthetic are applied prior to the procedure and Brimonidine 0.2% bid is used fo a week after the procedure together with topical dexamethasone ophthalmic solution.
Primary Outcome Measure Information:
Title
correction of posterior iris bowing
Description
The posterior iris bowing is at the basis of pigment dispersion pathology and so the correction of this posterior bowing halts the disease process at its very roots. Correction means either flattening or anterior bowing of iris (a change from negative bowing values to zero bowing or positive bowing values)
Time Frame
Baseline documentation of posterior bowing by anterior segment OCT followed by one week, one month, three months follow up by anterior segment OCT for changes in iris configuration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pigment dispersion syndrome/glaucoma confirmed by either clinical signs or imaging with documented posterior iris bowing. Exclusion Criteria: Active or history of Uveitis. Pupil size > 7mm in mesopic conditions. Previous Iris-based laser procedures e.g. Iridotomy, Iridoplasty
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Ameen Ismail, MBBCh
Phone
00201067964547
Email
am178@fayoum.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Sherin Sadek, PhD
Phone
00201006232012
Email
sh.sadek@gmail.com
Facility Information:
Facility Name
Fayoum University Hospitals
City
Fayoum
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Somaya Al Gohary, PhD
Phone
+200846300587
Email
smg02@fayoum.edu.eg
First Name & Middle Initial & Last Name & Degree
Nader Shaaban, PhD
Phone
+200846300587
Email
nsz00@fayoum.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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A Novel Argon Laser Iridoplasty for Pigment Dispersion Syndrome

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