Last updated: May 11, 2023
Sponsor: BelkinVision
Overall Status: Trial Not Available
Phase
N/A
Condition
Circulation Disorders
Glaucoma
Williams Syndrome
Treatment
DSLT
Clinical Study ID
NCT05043831
China-2021-01
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 40 years or older, any gender, of Chinese Han ethnicity, with corrected visualacuity > 6/60 in both eyes
- Open angle glaucoma including exfoliative or pigmentary glaucoma or ocularhypertension.
- IOP ≥ 22mmHg to ≤35mmHg (after washout of any IOP-lowering medications) forparticipants.
- Gonioscopically visible scleral spur for 360 degrees without indentation
- Ability to visualize the peri-limbal sclera for 360 degrees (using a lid speculum)
- Willing and able to participate in the 12-month study, to comply with the studyprocedures and to adhere to the follow-up schedule.
- Participant capable of giving informed consent
Exclusion
Exclusion Criteria:
- Contraindications to conventional laser trabeculoplasty (e.g., corneal abnormalities,etc.)
- Angle Closure Glaucoma
- Congenital or developmental glaucoma
- Secondary glaucoma except exfoliative or pigmentary glaucoma
- Presence of any Peripheral Anterior Synechiae (PAS) in the study eye
- Inability to conduct a reliable visual field (defined as fixation losses, falsepositives or false negatives greater than 33%)
- Any of the following visual field findings using the Humphrey visual field analyzerthe SITA-standard 24-2 program:
- A visual field MD of worse than -12dB
- Greater than or equal to 75% of points depressed below the 5% level and greaterthan or equal to 50% of points depressed below the 1% level on the PD plot.
- At least 50% of points (i.e 2 or more) within the central 5 degrees with asensitivity ≤0dB on the decibel plot
- Points within the central 5 degrees of fixation with a sensitivity <15 dB in bothhemifields on the decibel plot
- A visual field MD of worse than -12dB in the fellow eye
- Cup:Disc Ratio of more than 0.8
- More than three hypotensive medications required (combination drops are considered as 2 medications)
- Prior incisional or laser glaucoma surgery (including previous SLT or LPI) in thestudy eye.
- Prior corneal refractive surgery
- Complicated cataract surgery ≤ 6 months prior to enrollment
- Presence of visually significant cataract in the opinion of the investigator
- Clinically significant disease in either eye as determined by the Investigator.
- Clinically significant amblyopia in either eye
- Dense pigmentation or haemorrhage in the peri-limbal conjunctiva or anterior sclera
- Women who are pregnant or may become pregnant during the course of the study.
- In the opinion of the investigator the participant might require other ocular surgerywithin the 12-month follow-up period, unless for further reduction of their IOP
- Concurrent treatment with topical, nasal, inhaled or systemic steroids.
- Uncontrolled systemic disease that could impact the ability of the participant toattend follow up visits as per the discretion of the investigator.
- Participation in another clinical study, not including a GLAUrious sub-study
Study Design
Treatment Group(s): 1
Primary Treatment: DSLT
Phase:
Study Start date:
October 15, 2021
Estimated Completion Date:
April 15, 2023