Evaluation of the Compatibility of Different Eye Lid Retractors to the Direct Selective Laser Trabeculoplasty (DSLT) Procedure

Not Applicable

Completed

• Conditions: OAG - Open-Angle Glaucoma
• Interventions: Device: Lid retractor placement

• Registration Number: NCT05271734
• Lead Sponsor: BelkinVision

Brief Summary

Direct Selective Laser Trabeculoplasty (DSLT) is an emerging therapeutic technology to treat glaucoma. DSLT was previously tested in 2 clinical trials and demonstrated promising safety and efficacy results in reducing the patient's intra ocular pressure.

Experience gained in the previous clinical studies indicates that a full exposure of the limbal area may be a challenge in patients with narrow palpebral fissures, narrow or floppy eyelids, and patients with deep-set eyes.

Detailed Description

The DSLT procedure is carried out in the doctor's office while the patient sits in front of the DSLT device (termed the "Eagle" device) for couple of minutes.

In this procedure, 120 laser applications are performed around the full circumference of the ocular limbus, after the system automatically recognizes the limbal target area. It is therefore essential that a full exposure of 3600 limbal area will be achieved, and this is done by placing an eye lid retractor (speculum) in the treated eye at the beginning of the procedure.

The purpose of this study is to evaluate the compatibility of different types of lid retractors. The lid retractors will be tested in adult volunteers visiting the study eye clinic for any reason.

Study Timeline

• Study Start: 2021-06-06
• Status Verified: 2022-02
• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-09
• Primary Completion: 2022-06-15
• Study Completion: 2022-08-15
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

• Prior incisional ocular surgery or ocular trauma in the tested eye.
• Women who are pregnant.
• Any medical condition that interferes with the subject's ability to sit steady in front of the Eagle device.
• Known allergy to local anaesthesia eye drops.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm -lid retractor placement	Lid retractor placement	Placement of a lid retractor the find out if the corneal limbus is exposed to 360 degrees

Primary Outcome Measures

Name	Time	Method
Limbus Exposure	Baseline	Full 360° Limbus exposure while subject is sitting.

Trial Locations

Locations (1)

Akhali Mzera Eye Clinic; 🇬🇪 Tbilisi, Georgia