A Novel Argon Laser Iridoplasty for Pigment Dispersion Syndrome

NCT05231928 | Unknown

• 1 other identifier: R 211
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pigment Dispersion Syndrome; Pigmentary Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

Study Arms (1)

Argon Laser Iridoplasty

EXPERIMENTAL

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.

Procedure: Argon Laser Iridoplasty

Interventions

Argon Laser Iridoplasty PROCEDURE

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.

Argon Laser Iridoplasty

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University Hospitals

Al Fayyum, Egypt

RECRUITING

MeSH Terms

Conditions

Glaucoma-Related Pigment Dispersion Syndrome; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Central Study Contacts

Ahmed Ameen Ismail, MBBCh

CONTACT

00201067964547; am178@fayoum.edu.eg

Sherin Sadek, PhD

CONTACT

00201006232012; sh.sadek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant of ophthalmology

Model Details: Interventional, longitudinal, prospective, uncontrolled case series

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: February 9, 2022
• Study Start: December 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: February 1, 2023
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)