Direct Selective Laser Trabeculoplasty for Primary Open Angle Glaucoma and Ocular Hypertension in Ethnic Chinese Population The Zhuiguang Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glaucoma, Open-Angle
- Sponsor
- BelkinVision
- Primary Endpoint
- IOP reduction from baseline to 6 months
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective of this study is to evaluate the effectiveness (Intra-Ocular Pressure lowering) and safety of Direct Selective Laser Trabeculoplasty (DSLT) in ethnic Chinese subjects with Primary Open Angle Glaucoma or Ocular Hypertension.
Detailed Description
Glaucoma, which is very common disease in China, 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 hypertension by prescribing eye drops. Unfortunately, there can be side effects associated with the use of these eye drops and there are reports of non-compliance due to difficulties in inserting these drops, all of which can impact on how effective this treatment regimen is. The purpose of this study is to assess how well the new automated DSLT device for laser treatment of glaucoma or ocular hypertension works in comparison with the standard SLT in ethnic Chinese population and determine that it is as effective in reducing intraocular pressure. DSLT or SLT will be performed in the study eye according to the randomization assignment. 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 will be a baseline visit, where continued eligibility is confirmed. Following confirmation of continued eligibility, 50% of patients being randomized to each treatment group. Randomization will be to a pre-determined randomization list. Only one eye per participant will be included in the study and they will be treated using either DSLT or SLT as per the randomized treatment allocation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 40 years or older, any gender, of Chinese Han ethnicity, with corrected 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) for participants.
- •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 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, 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
Outcomes
Primary Outcomes
IOP reduction from baseline to 6 months
Time Frame: 6 months
The primary effectiveness endpoint is the difference between the two treatment groups' change-from-baseline IOP, where change-from-baseline is defined as the difference between baseline (washed out for medicated patients) IOP and (washed out for medicated patients) IOP measured at 6 months for each subject.
Secondary Outcomes
- Subjects with at least 20% IOP reduction(6 months)
- Change in medications(12 months)
- Treatment failures(r months)
- Mean percentage IOP reduction(3, 6, 12 months)
- Adverse events(6, 12 months)