Health Condition 1: H251- Age-related nuclear cataract
Conditions
Interventions
Intervention1: Bio-Hyalur Plus (Sodium Hyaluronate 1.4%): Ophthalmic viscosurgical device to be used intraoperatively to fill the anterior chamber & coat the endothelium during cataract surgery.
Cont
Sponsors
Biotech Ophthalmics Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1) Unilateral/Bilateral 2) Age18yearorgreater 3) Cataractforwhichphacoemulsificationextractionandposterior chamber IOL implantation was planned in at least one eye of the patient 4) Clearintraocularmediaotherthancataract 5) Signedinformedconsent 6) Patient who are willing to attend all the regular follow-up examinations as per the study schedule.
Exclusion criteria
Exclusion criteria: 1) Concurrent participation or participation in the last 30 days in any other clinical trial. 2) Historyofprevioussteroid-inducedIOP 3) Patient with pigment dispersion syndrome 4)Taking medications that may affect vision,IOP,or ease of cataract 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) Uncontrolledsystemicoroculardisease. 7) Historyofoculartraumaorpriorocularsurgery 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 15) Vulnerable subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare Bio-Hyalur Plus with the Protectalon 1.4% in terms of the incidence of IOP observations above 30 mmHg.Timepoint: intra-operativevisit,8-hours, 24 hours, 7 day, 30 day, 90 day post-operative and as and when occur] | — |
Secondary
| Measure | Time frame |
|---|---|
| The Endothelial Cell Density Changes from pre-operative to 3 months post-operative for both OVD group. 2 The grade of inflammation 3 The grade of corneal clarity 4 The change in Visual acuity (UCVA & BCVA) from baseline will be presented by descriptive statistics for the 1-month and 3- month postoperative by OVD groups. 5 The frequency and proportion of monocular BCVA will be reported over time by visual acuity line. 6 The frequency and proportion of monocular UCVA will be reported over time by visual acuity line. 7 The change in corneal thickness from baselineTimepoint: intra-operativevisit,8-hours, 24 hours, 7 day, 30 day, 90 day post-operative and as and when occur] | — |
Countries
India
Contacts
Public ContactDrShreyas Ramamurthy
The Eye Foundation
Outcome results
None listed