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

University Tunis El Manar15 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Conjunctiva Cornea

Interventions

conjunctival biopsy after micropulse transscleral laser therapyPROCEDURE

During MicroPulse TLT, all patients received periocular anesthesia, with an injection of 5 to 10 ml of Lidocaine (Xylocaine 5mg/ml ®) to achieve complete anesthesia. The investigators employed the 810 nm Cyclo G6® Laser in its MicroPulse® mode (Iridex Corporation, Mountain View, CA, USA) and delivered laser energy to the eye using the second-generation MicroPulse P3® probe (Iridex Corporation, Mountain View, CA, USA). The laser was calibrated to generate a power output of 2500 mW, and a MicroPulse duty cycle of 31.3%. The curved end of the probe's footplate (bunny ears) was positioned 0.5 to 1 mm away from the corneoscleral limbus, maintaining a perpendicular orientation to the eyeball. Following the laser therapy, an immediate conjunctival biopsy measuring 2 \* 2 mm and avoiding the laser-treated region was performed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mohamed Taher Maamouri Hospital

Nabeul, Tunisia

Outcomes

Primary Outcomes

conjunctival inflammation or fibrosis

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%

Time frame: 1 month

intraocular pression

change in intraocular pression

Time frame: 6 months

ocular surface disease index score

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

Time frame: 6 months

Data from ClinicalTrials.gov

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