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NCT Number: NCT06353776

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

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.

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Key information

Conditions

Conjunctiva Cornea Corneal Diseases Eye Diseases Fibrosis Glaucoma Inflammation Ocular Hypertension Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed Taher Maamouri Hospital

Nabeul, 8000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conjunctival biopsy after micropulse transscleral laser therapy

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.

Primary outcomes

  1. conjunctival inflammation or fibrosis

    Time frame: 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%

  2. intraocular pression

    Time frame: 6 months

    change in intraocular pression

  3. ocular surface disease index score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 9, 2024
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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