Health Condition 1: H401- Open-angle glaucoma Health Condition 2: H402- Primary angle-closure glaucoma
Conditions
Interventions
Intervention1: Prednisolone acetate 1%: Additional use of prednisolone acetate 1% eye drops one drop 4 times per day for 7 days (± 2 days) prior to surgery
Intervention2: Fluromethalone 0.1%: Addition
Sponsors
Medical research foundation, Sankara Nethralaya
Eligibility
Inclusion criteria
Inclusion criteria: Primary glaucoma on topical IOP lowering medication for at least 6 months Glaucoma not controlled on medical therapy Patient intolerant to topical IOP lowering medication for IOP control Glaucoma controlled on medical therapy but patient with more than two IOP lowering medication undergoing cataract surgery Age atleast eighteen years or older Snellen best corrected visual acuity of 6/60 or better
Exclusion criteria
Exclusion criteria: Any patient with uncontrolled IOP and glaucomatous damage requiring surgical intervention at the earliest and hence unable to take the preoperative topical steroid course Active severe inflammation requiring topical steroids within the last 3 months History of Yttrium Aluminum Garnet peripheral iridotomy (YAG PI) within the last 3 months Those with history of laser trabeculoplasty Prior surgery other than uncomplicated clear corneal phacoemulsification Other ocular pathology including retinal pathology, uveitis Secondary glaucoma including but not limited to steroid induced glaucoma, ICE syndrome, pseudoexfoliation glaucoma, pigment dispersion syndrome, neovascular glaucoma History of ocular trauma in the eye planned for trabeculectomy Myopia more than 6D/ pathological myopia One eyed patients Pregnant or nursing women Concurrent or steroid use within last 3months for other diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete success- IOP of greater than or equal to 6mmHg or less than or equal to 18 mmHg on Goldmann applanation tonometry, without the need for additional medication or procedure for IOP control, or vision threatening complications (endophthalmitis, retinal detachment, large choroidal detachments, choroidal hemorrhage etc) Timepoint: 6 weeks, 4-5 months and 10-12 months post surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Atleast 3 point total difference on bleb assessment of photographTimepoint: 6 weeks, 4-5 months and 10-12 months post surgery;Failure defined as IOP of less than 6 or greater than 18 mmHg on Goldmann applanation tonometry, need for additional procedure for IOP control, or vision threatening complications like endophthalmitis, retinal detachment, large choroidal detachments, choroidal hemorrhage etcTimepoint: 6 weeks, 4-5 months and 10-12 months post surgery;Number of medications used for IOP controlTimepoint: 6 weeks, 4-5 months and 10-12 months post surgery;Qualified success: additionally includes those with the criteria for success but additionally includes those with IOP control obtained on use of on IOP lowering medication alsoTimepoint: 6 weeks, 4-5 months and 10-12 months;Qualitative and quantitative assessment of ocular fluid and tissue for inflammatory markers among the three groups (in a subset)Timepoint: At enrollment(tear sample) and on day of surgery (ocular fluid and tissue) | — |
Countries
India
Contacts
Public ContactParivadhini Annadurai
Medical research foundation, Sankara Nethralaya
Outcome results
None listed