Health Condition 1: H251- Age-related nuclear cataract
Conditions
Interventions
Intervention1: Biohyalur 1%: Ophthalmic Viscoelastic agent to be used for coating the corneal endothelium as required while performing cataract surgery.
Control Intervention1: Protectalon 1.4%: Ophtha
Sponsors
Biotech Ophthalmics Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1) Unilateral/Bilateral 2) Age 18 year or greater 3) Cataract for which phacoemulsification extraction and posterior chamber IOL implantation was planned in at least one eye of the patient 4) Clear intraocular media other than cataract 5) Signed informed consent 6) Patient who are willing to attend all the regular follow-up examinations as per the study schedule.
Exclusion criteria
Exclusion criteria: 1) Concurrentparticipationorparticipationinthelast30daysinany other clinical trial. 2) History of previous steroid- induced IOP 3) Patient with pigment dispersion syndrome 4) Takingmedicationsthatmayaffectvision,IOP,oreaseofcataract surgery (e.g., Flomax, glaucoma medications, etc.) 5) Acute or chronic disease or illness that would increase risk or confound study results (e.g., diabetes mellitus, immunocompromised, etc.) 6) Uncontrolled systemic or ocular disease. 7) History of ocular trauma or prior ocular surgery 8) Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies) 9) Knownpathologythatmayaffectvisualacuity;particularlyretinal changes that affect vision (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.) 10) Any visual disorder predicted to cause future acuity loss to a level of 0.3 LogMAR or worse 11) Pseudoexfoliation 12) Ocular hypertension ( >22 mm Hg) or glaucomatous changes in the optic nerve. 13) Endothelial cell counts lower than 1500 cells/mm2 preoperatively (based on the lowest value of three cell counts performed by technician at investigative site) 14) Patient is pregnant, planned to become pregnant, lactating or had another condition associated with the fluctuation of hormones that could lead to refractive changes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare Bio-Hyalur with the Protectalon 1.4% in terms of the incidence of IOP observations above 30 mmHg.Timepoint: 1. Post-operative 8 hours ± 2 hours 2. Post-operative 24 hours ± 4 hours 3. Post-operative 7 Days ± 2 days 4. Post-operative 30 days ± 7 days 5. Post-operative 90 days ± 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Intraocularpressure 2) Changes in cell density of the corneal endothelium 3) Intraocular Inflammation with Grade of Inflammation 4) Corneal thickness (μm) 5) Corneal ClarityTimepoint: 1. Post-operative 8 hours ± 2 hours 2. Post-operative 24 hours ± 4 hours 3. Post-operative 7 Days ± 2 days 4. Post-operative 30 days ± 7 days 5. Post-operative 90 days ± 14 days | — |
Countries
India
Contacts
Public ContactDrShreyas Ramamurthy
The Eye Foundation
Outcome results
None listed