NCT05271734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

January 23, 2023

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

February 17, 2022

Last Update Submit

January 19, 2023

Conditions

OAG - Open-Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Limbus Exposure

    Full 360° Limbus exposure while subject is sitting.

    Baseline

Study Arms (1)

Single arm -lid retractor placement

EXPERIMENTAL

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

Device: Lid retractor placement

Interventions

Lid retractor placementDEVICE

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

Single arm -lid retractor placement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akhali Mzera Eye Clinic

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2022

First Posted

March 9, 2022

Study Start

June 6, 2021

Primary Completion

June 15, 2022

Study Completion

August 15, 2022

Last Updated

January 23, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

GE(1)