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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05271734

Enrollment

Registered

2022-03-09

Start date

2021-06-06

Completion date

2022-08-15

Last updated

2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OAG - Open-Angle Glaucoma

Brief 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.

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.

Interventions

DEVICELid retractor placement

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Georgia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026