Health Condition 1: H251- Age-related nuclear cataract
Conditions
Interventions
Intervention1: Eyevisc 2.4% viscoelastic agent: EYEVISC™ 2.4% (Hydroxypropyl Methylcellulose 2.4 %) (Biotech
Vision Care Pvt. Ltd.)
Control Intervention1: NOT APPLICABLE: NOT APPLICABLE
Sponsors
Biotech Ophthalmics Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Unilateral/Bilateral 2) Age = 45 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. 7) Patients with Grade I to III cataract and used OVDs 8) Patients that have healthy eyes excluding the formation of cataract. 9) Given consent to use device related data for scientific purpose. 10) No other ocular pathology or condition and pupil dilation that was greater than 7.0 mm
Exclusion criteria
Exclusion criteria: 1) Concurrent participation or participation in the last 30 days in any other clinical trial. 2) History of previous steroid - induced IOP 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) Uncontrolled systemic or ocular disease. 7) Previous intra ocular or corneal surgery or history of ocular trauma. 8) Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies). 9) Known pathology that may affect visual acuity; particularly retinal 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. 16) Black, Brunescent, traumatic or subluxated cataract. 17) Patient who had Glaucoma, Pseudo exfoliation Syndrome with Iris atrophy, uveitis, Proliferative diabetic retinopathy at the time of surgery (Random blood sugar level more than 140 mg/dl). 18) A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, Iridocyclitis, rubeosis iritis). 19) Intraocular pressure (IOP) higher than 24 mm Hg 20) Surgery of the contralateral eye performed or planned within a period of 7 days before or after the surgery of the studied eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants with postoperative intraocular pressure of at least 30 mm Hg [Time Frame: 3 Months] 2. Percent change in Mean Epithelial Cell Density (ECD) (Safety end point) [Time Frame: 3 Months]Timepoint: 1. Percentage of participants with postoperative intraocular pressure of at least 30 mm Hg [Time Frame: 3 Months] 2. Percent change in Mean Epithelial Cell Density (ECD) (Safety end point) [Time Frame: 3 Months] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Corneal thickness 2. Intraocular Inflammation with Grade of Inflammation 3. Corneal Clarity 4. CV in cell size 5. Cell area 6. Number of cell analyzed 7. Cell Hexagonality 8. Adverse Event/complicationTimepoint: Baseline & 3 months | — |
Countries
India
Contacts
Public ContactDrShreyas Ramamurthy
The Eye Foundation
Outcome results
None listed