NCT05271734

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: BelkinVision · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• OAG - Open-Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Lid retractor placement	Insertion of a lid retractor to find out if the corneal limbus is exposed in 360 degress

Timeline

• Start date: 2021-06-06
• Primary completion: 2022-06-15
• Completion: 2022-08-15
• First posted: 2022-03-09
• Last updated: 2023-01-23

Locations

1 site across 1 country: Georgia