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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05271734
Other study ID # 2021-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 6, 2021
Est. completion date August 15, 2022

Study information

Verified date February 2022
Source Belkin Laser Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 15, 2022
Est. primary completion date June 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Georgia Akhali Mzera Eye Clinic Tbilisi

Sponsors (1)

Lead Sponsor Collaborator
Belkin Laser Ltd.

Country where clinical trial is conducted

Georgia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Limbus Exposure Full 360° Limbus exposure while subject is sitting. Baseline
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