A study to assess an automated laser device to treat glaucoma
- Conditions
- GlaucomaEye Diseases
- Registration Number
- ISRCTN14033075
- Lead Sponsor
- BELKIN Laser Ltd
- Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34433548/ protocol (added 27/08/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 276
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method