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

Cornea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06353776
• Other study ID #: 02052023
• Status: Completed
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: April 2024
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cornea

Intervention

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.

Locations

Country	Name	City	State
Tunisia	Mohamed Taher Maamouri Hospital	Nabeul

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%	1 month
Primary	intraocular pression	change in intraocular pression	6 months
Primary	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	6 months