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

OAG - Open-Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05271734
• Other study ID #: 2021-02
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• OAG - Open-Angle Glaucoma

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