None listed
Conditions
Brief summary
The study is looking to see if adding an extra eye drop (Brinzolamide) to the normal eye drops (Prednisolone acetate and Chloramphenicol) patients receive after macular hole repair operation, will improve their vision in the long term. Most people after macular hole surgery have some fluid underneath the macula that hangs around for many months even though the hole has closed. Fluid in this position prevents the sight from improving as quickly as we’d like and we believe the extra eye drop we’re trying may make the fluid go away faster. This may make sight better long term than it would be if we just used the normal eye drops. This drop has been used in other forms of macular disease to improve fluid resolution with success. The extra drop we’re trying in this study is already used by many thousands of New Zealanders with glaucoma and is known to be very safe. However, as with all eye drops there is a very small chance that patients may experience side effects. We will be randomising patients with fluid underneath the macula post-surgery to either receive the extra drop or just the standard drop regime via computer assisted randomisation. Patients may be required to attend one additional clinic appointment to determine the efficacy of the treatment.
Interventions
Randomised controlled trial looking at eyes that have residual subretinal fluid with hole closure after macular hole repair surgery
1 arm of the study will have standard of care treatment to macular hole eyes after repair surgery and the other arm will receive additional Brinzolamide drops postoperatively. Brinzolamide tartrate 0.2% eye drops will be used to the operated eye twice a day, from 2 weeks out from macular hole repair surgery until the subretinal fluid at the macula has cleared fully
Randomised controlled trial looking at eyes that have residual subretinal fluid with hole closure after macular hole repair surgery 1 arm of the study will have standard of care treatment to macular hole eyes after repair surgery and the other arm will receive additional Brinzolamide drops postoperatively. Brinzolamide tartrate 0.2% eye drops will be used to the operated eye twice a day, from 2 weeks out from macular hole repair surgery until the subretinal fluid at the macula has cleared fully or until 1 year out from the surgery, whichever is the earliest. One drop of the drug is the standard dose. Each participant will be asked at each visit if they've missed any doses.
Sponsors
Stephen Guest
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with macular hole repair and residual submacular fluid at the 2 week postoperative timepoint
Exclusion criteria
Allergy to carbonic anhydrase inhibitors Underlying macular pathology other than macular hole ie age related macular degeneration or diabetic maculopathy or vein occlusion Traumatic macular holes
Outcome results
None listed