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Completed

NCT Number: NCT05271734

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

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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Key information

Conditions

OAG - Open-Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akhali Mzera Eye Clinic

Tbilisi, Georgia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lid retractor placement

Device

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

Primary outcomes

  1. Limbus Exposure

    Time frame: Baseline

    Full 360° Limbus exposure while subject is sitting.

Sponsors and collaborators

Lead sponsor

BelkinVision

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2022
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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