Status:
COMPLETED
A Study to Assess an Automated Laser Device for Direct Selective Laser Trabeculoplasty
Lead Sponsor:
BelkinVision
Collaborating Sponsors:
European Commission
Universita degli Studi di Genova
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Glaucoma is an eye disease that results in damage to the optic nerve that progresses over time. One of the main risk factors in glaucoma is an increase in intraocular pressure, caused by a build-up of...
Detailed Description
Glaucoma can result in blindness if left untreated and as such it is extremely important to diagnose and treat the condition. Usually doctors treat the first symptoms of glaucoma or ocular hypertensi...
Eligibility Criteria
Inclusion
- Age 40 years or older, with visual acuity \> 6/60 in both eyes
- Open angle glaucoma including exfoliative or pigmentary glaucoma or ocular hypertension
- IOP ≥ 22mmHg to ≤35mmHg (after washout of any IOP-lowering medications)
- 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 study procedures and to adhere to the follow-up schedule
- Participant capable of giving informed consent
Exclusion
- 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, false positives or false negatives greater than 33%)
- Any of the following visual field findings using the Humphrey visual field analyzer the 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 greater than 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 a sensitivity ≤0dB on the decibel plot
- Points within the central 5 degrees of fixation with a sensitivity \<15 dB in both hemifields 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 mediations required
- Prior incisional or laser glaucoma surgery (including previous SLT) in the study 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 study
- In the opinion of the investigator the participant might require other ocular surgery within 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 to attend follow up visits as per the discretion of the investigator
- Participation in another clinical study
Key Trial Info
Start Date :
October 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2022
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT03750201
Start Date
October 19 2018
End Date
May 22 2022
Last Update
July 24 2025
Active Locations (8)
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1
Soroka Medical Center
Beersheba, Israel
2
Rambam Medical Center
Haifa, Israel
3
Wolfson Medical Center
Holon, Israel
4
Shaare Zedek Medical Center
Jerusalem, Israel