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

January 19, 2023 updated by: Belkin Laser Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Georgia
      • Tbilisi, Georgia
        • Akhali Mzera Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm -lid retractor placement
Placement of a lid retractor the find out if the corneal limbus is exposed to 360 degrees
Device: Lid retractor placement
Insertion of a lid retractor to find out if the corneal limbus is exposed in 360 degress

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Limbus Exposure
Time Frame: Baseline
Full 360° Limbus exposure while subject is sitting.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belkin Laser Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2021

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

August 15, 2022

Study Registration Dates

First Submitted

February 17, 2022

First Submitted That Met QC Criteria

March 7, 2022

First Posted (Actual)

March 9, 2022

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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