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CompletedNCT05271734Updated Jan 23, 2023

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

An interventional study of Lid retractor placement in OAG - Open-Angle Glaucoma, sponsored by BelkinVision. Completed at 1 site in Georgia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-23.

Sponsored by BelkinVision · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jun 2021, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • OAG - Open-Angle Glaucoma

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03

In context

Glaucoma, Open-Angle

929 studies on the registry are indexed under Glaucoma, Open-Angle; 122 are open to participants now.

This study's enrollment of 24 is below the median of 80 across 700 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

BelkinVision is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Single arm -lid retractor placement

    Placement of a lid retractor the find out if the corneal limbus is exposed to 360 degrees

    Device: Lid retractor placement

Interventions

  • DeviceLid retractor placement

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

06

What researchers measure

Primary outcomes

  1. Limbus Exposure

    Full 360° Limbus exposure while subject is sitting.

    Time frame: Baseline

07

Study locations

1 site
  • Akhali Mzera Eye Clinic
    Tbilisi, Georgia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05271734
Lead sponsor
BelkinVision
Responsible party
Sponsor
First posted
Mar 9, 2022
Start date
Jun 6, 2021
Primary completion
Jun 15, 2022
Completion
Aug 15, 2022
Last update
Jan 23, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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