MicroPulse Transscleral Laser Therapy and Its Short-term Impact on Ocular Surface

Not Applicable

Completed

• Conditions: Conjunctiva; Cornea
• Interventions: Procedure: conjunctival biopsy after micropulse transscleral laser therapy

• Registration Number: NCT06353776
• Lead Sponsor: University Tunis El Manar

Brief Summary

MicroPulse transscleral laser therapy (TLT) is proven to be effective in reducing intraocular pressure with minimal complications in either primary or secondary glaucoma. However, its impact on the human ocular surface remains unexplored. This study aims to bridge this gap by examining the clinical and histopathological effects of MicroPulse TLT on the ocular surface.

Detailed Description

This prospective study, conducted at Mohamed Taher Maamouri University Hospital in Nabeul, Tunisia, investigates the clinical and histopathological short-term effects of MicroPulse transscleral laser therapy (TLT) on the ocular surface. The study involves 16 eyes from 15 adult patients. Participants underwent MicroPulse TLT, followed by conjunctival biopsies for the analysis of inflammation and fibrosis. Participants also benefited from ophthalmological examination and responded to the Ocular Surface Disease Index (OSDI) questionnaire before and after MicroPulse TLT.

Study Timeline

• Study Start: 2023-05-03
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Study First Submitted: 2024-03-25
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-02
• Last Update Submitted: 2024-04-02
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Age > 18 years old
• Non-controlled open-angle glaucoma despite undergoing maximal medical therapy
• Poor therapeutic adherence
• Local or general intolerance to topical treatments.

Exclusion Criteria

• Ophthalmic or general diseases that could potentially impact the conjunctiva such as symblepharon, ocular injury, or prior eye surgery
• Pevious transscleral laser therapy applied to the same eye
• angle-closure glaucoma
• active ocular inflammation
• a non-functional eye (absence of light perception)
• scleral thinning

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MP-TLT + conjunctival biopsy	conjunctival biopsy after micropulse transscleral laser therapy	Participants underwent MicroPulse transscleral laser therapy, followed by conjunctival biopsies for the analysis of inflammation and fibrosis.

Primary Outcome Measures

Name	Time	Method
ocular surface disease index score	6 months	This score is calculated and ranges from 0 to 100 with the following interpretation: * 0 to 12 = Normal; * 13 to 22 = Mild ocular surface disease; * 23 to 32 = Moderate ocular surface disease; * 33 to 100 = Severe ocular surface disease
conjunctival inflammation or fibrosis	1 month	histological changes of the conjunctiva according to a scale ranging from 0 to 3, with the following interpretation: * Grade 0: no difference between the two samples; * Grade 1: increase in inflammation / fibrosis \< 33%; * Grade 2: increase in inflammation / fibrosis from 33% to 66%; * Grade 3: increase in inflammation / fibrosis \> 66%
intraocular pression	6 months	change in intraocular pression

Trial Locations

Locations (1)

Mohamed Taher Maamouri Hospital; 🇹🇳 Nabeul, Tunisia