NCT06353776

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University Tunis El Manar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Conjunctiva
• Cornea

Interventions

Type	Name	Description
PROCEDURE	conjunctival biopsy after micropulse transscleral laser therapy	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.

Timeline

• Start date: 2023-05-03
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2024-04-09
• Last updated: 2024-04-09

Locations

1 site across 1 country: Tunisia