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

NCT ID: NCT06353776

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-03
• Study Completion Date: 2023-10-31

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.

Conditions

Conjunctiva; Cornea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MP-TLT + conjunctival biopsy

Participants underwent MicroPulse transscleral laser therapy, followed by conjunctival biopsies for the analysis of inflammation and fibrosis.

Group Type: EXPERIMENTAL

conjunctival biopsy after micropulse transscleral laser therapy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

Walid Zbiba

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mohamed Taher Maamouri Hospital

Nabeul, , Tunisia

Countries

Tunisia

Other Identifiers

02052023

Identifier Type: -

Identifier Source: org_study_id