Back to resultsEvaluation of the Compatibility of Different Eye Lid Retractors to the Direct Selective Laser Trabeculoplasty (DSLT) Procedure
Primary Purpose
OAG - Open-Angle Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
Lid retractor placement
Sponsored by
About this trial
This is an interventional treatment trial for OAG - Open-Angle Glaucoma
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.
Sites / Locations
- Akhali Mzera Eye Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm -lid retractor placement
Arm Description
Placement of a lid retractor the find out if the corneal limbus is exposed to 360 degrees
Outcomes
Primary Outcome Measures
Limbus Exposure
Full 360° Limbus exposure while subject is sitting.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05271734
Brief Title
Evaluation of the Compatibility of Different Eye Lid Retractors to the Direct Selective Laser Trabeculoplasty (DSLT) Procedure
Official Title
Evaluation of the Compatibility of Different Eye Lid Retractors to the Direct Selective Laser Trabeculoplasty (DSLT) Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 6, 2021 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BelkinVision
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OAG - Open-Angle Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm -lid retractor placement
Arm Type
Experimental
Arm Description
Placement of a lid retractor the find out if the corneal limbus is exposed to 360 degrees
Intervention Type
Device
Intervention Name(s)
Lid retractor placement
Intervention Description
Insertion of a lid retractor to find out if the corneal limbus is exposed in 360 degress
Primary Outcome Measure Information:
Title
Limbus Exposure
Description
Full 360° Limbus exposure while subject is sitting.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Akhali Mzera Eye Clinic
City
Tbilisi
Country
Georgia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Compatibility of Different Eye Lid Retractors to the Direct Selective Laser Trabeculoplasty (DSLT) Procedure
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