Comparison of post-operative cycloplegia, miotics, and no treatment after Minimally Invasive Glaucoma Surgery: A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The change of PAS from baseline
Study Overview
Brief Summary
Minimally Invasive Glaucoma Surgeries (MIGS) have developed in recent years. These procedures are characterized by ab-interno microincisions, minimal trauma, a high safety profile, high efficacy, and fast recovery.
Although minimally invasive glaucoma surgeries (MIGS) have made significant advancements, they are not without failures. Studies indicate that failure rates for various MIGS procedures can range from 20% to 40%. (9-11) Several factors contribute to these failures, including postoperative intraocular pressure (IOP) spikes and heightened responses to steroids. Additionally, the formation of peripheral anterior synechiae (PAS) may lead to increased IOP after surgery, which can further raise the failure rates of these procedures.
Our study aims to investigate whether the use of cycloplegic drops postoperatively, which keeps the lens-iris diaphragm positioned posteriorly, can reduce the formation of PAS and lower the failure rates in patients undergoing MIGS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 3.00 Month(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Any diagnosed case of glaucoma, undergoing MIGS during the study period.
Exclusion Criteria
- •Any patient with blood dyscrasia.
Outcomes
Primary Outcomes
The change of PAS from baseline
Time Frame: Three months
The extent of PAS (in clock hours)
Time Frame: Three months
IOP and correlation to PAS
Time Frame: Three months
Secondary Outcomes
- Intraocular Pressure(3 months)
- Reduction in antiglaucoma meds(3 months)
Investigators
Sushmita Kaushik
Post Graduate Institute of Medical Education and Research, Chandigarh