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

Study Overview
=================
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.

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

Conditions
-----------------
OAG - Open-Angle Glaucoma

Intervention / Treatment
-----------------
* Device: Lid retractor placement


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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