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

BELKIN Vision

Status

Completed

Conditions

OAG - Open-Angle Glaucoma

Treatments

Device: Lid retractor placement

Study type

Interventional

Funder types

Industry

Identifiers

NCT05271734

2021-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria.

Adult volunteers (age ≥18 years old) of both sexes visiting the study eye clinic for any reason.
Willing and able to participate in the study and to comply with the study procedures.
Participant capable of giving informed consent.

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.