Glaucoma Eye Diseases Glaucoma
Conditions
Interventions
Interventions as of 16/11/2018:
Eligible patients who sign the informed consent will be enrolled at each of the study sites, and undergo a washout (in the case of being medicated). After washout there
Sponsors
BELKIN Laser Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 40 years or older, with visual acuity > 6/60 in both eyes 2. Primary open-angle glaucoma including exfoliative or pigmentary glaucoma; added 03/06/2020: or ocular hypertension 3. IOP = 22mmHg to =35mmHg (in the case of a medicated patient at the baseline visit following washout and in the case of a naïve (newly diagnosed) patient at the time of screening) 4. Gonioscopically visible scleral spur for 360 degrees without indentation 5. Ability to visualize the peri-limbal sclera for 360 degrees (using a speculum) 6. Willing and able to participate in the 12-month study, to comply with the study procedures and to adhere to the follow-up schedule 7. Participant capable of giving informed consent
Exclusion criteria
Exclusion criteria: Individuals with the following characteristics will be excluded from the study (unless specified otherwise, all ocular criteria refer to the study eye only): 1. Contraindications to conventional laser trabeculoplasty (e.g. corneal abnormalities, etc) 2. Angle Closure Glaucoma 3. Congenital or developmental glaucoma 4. Secondary glaucoma except exfoliative or pigmentary glaucoma 5. Presence of any Peripheral Anterior Synechiae (PAS) in the study eye 6. Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%) 7. Any of the following visual field findings using the Humphrey visual field analyzer the SITA-standard 24-2 program: 7.1. A visual field MD of less than -12dB 7.2. 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 7.3. At least 50% of points (i.e., 2 or more) within the central 5 degrees with a sensitivity =0dB on the decibel plot 7.4. Points within the central 5 degrees of fixation with a sensitivity <15 dB in both hemifields on the decibel plot 8. A visual field MD of less than -12dB in the fellow eye 9. Cup:Disc Ratio of more than 0.8 10. More than two hypotensive mediations required 11. Prior incisional or laser glaucoma surgery 12. Prior corneal refractive surgery 13. Complicated cataract surgery = 6 months prior to enrollment 14. Presence of visually significant cataract in the opinion of the investigator 15. Clinically significant disease in either eye as determined by the Investigator 16. Clinically significant amblyopia in either eye 17. Women who are pregnant or may become pregnant during the course of the study 18. Added 16/03/2018: Dense pigmentation or haemorrhage in the peri-limbal conjunctiva or anterior sclera 19. 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 20. Concurrent treatment with topical, nasal, inhaled or systemic steroids 21. Uncontrolled systemic disease that could impact the ability of the participant to attend follow up visits as per the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary effectiveness endpoint: The primary effectiveness endpoint is the difference between the two treatment groups between the mean (washed out for medicated patients) baseline IOP and the mean (washed out for medicated patients) IOP measured at 6 months. Eligible patients on medications will be washed out at both treatment groups. The mean intraocular pressure (IOP) at baseline before the treatment and washed out IOP at 6 months will be measured by Goldmann Applanation Tonometry. The difference between the two treatment groups in change between mean washout baseline and 6-month IOP will be estimated. Safety endpoints: Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean percentage reduction in IOP, measured by Goldmann Applanation Tonometry at 3, 6, and 12 months 2. Number of medications being taken for each eye at baseline (before treatment) and 12 months | — |
Countries
England, Israel, Italy, Northern Ireland, United Kingdom
Contacts
Public ContactDorit Raz-Prag
Outcome results
None listed