NCT06353776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

March 25, 2024

Last Update Submit

April 2, 2024

Conditions

ConjunctivaCornea

Keywords

MicroPulsetransscleral laser therapyocular surfaceinflammationfibrosisglaucoma

Outcome Measures

Primary Outcomes (3)

  • 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

  • intraocular pression

    change in intraocular pression

    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

    6 months

Study Arms (1)

MP-TLT + conjunctival biopsy

EXPERIMENTAL

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

Procedure: conjunctival biopsy after micropulse transscleral laser therapy

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.

MP-TLT + conjunctival biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years old
  • Non-controlled open-angle glaucoma despite undergoing maximal medical therapy
  • Poor therapeutic adherence
  • Local or general intolerance to topical treatments.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Taher Maamouri Hospital

Nabeul, 8000, Tunisia

Location

MeSH Terms

Conditions

Corneal DiseasesInflammationFibrosisGlaucoma

Condition Hierarchy (Ancestors)

Eye DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOcular Hypertension

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 9, 2024

Study Start

May 3, 2023

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations

TU(1)