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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-06

Study Completion Date

2022-08-15

Brief Summary

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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.

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Detailed Description

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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

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OAG - Open-Angle Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm -lid retractor placement

Placement of a lid retractor the find out if the corneal limbus is exposed to 360 degrees

Group Type EXPERIMENTAL

Lid retractor placement

Intervention Type DEVICE

Insertion of a lid retractor to find out if the corneal limbus is exposed in 360 degress

Interventions

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Lid retractor placement

Insertion of a lid retractor to find out if the corneal limbus is exposed in 360 degress

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes