This study will assess the outcome and efficacy of a new viscoelastic device which is used for protecting the corneal endothelium during cataract surgery.
- Conditions
- Health Condition 1: H251- Age-related nuclear cataract
- Registration Number
- CTRI/2023/11/060182
- Lead Sponsor
- Biotech Ophthalmics Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Percentage of participants with postoperative intraocular pressure <br/ ><br>of at least 30 mm Hg [Time Frame: 3 Months] <br/ ><br>2. Percent change in Mean Epithelial Cell Density (ECD) (Safety <br/ ><br>end point) [Time Frame: 3 Months]Timepoint: 1. Percentage of participants with postoperative intraocular pressure <br/ ><br>of at least 30 mm Hg [Time Frame: 3 Months] <br/ ><br>2. Percent change in Mean Epithelial Cell Density (ECD) (Safety <br/ ><br>end point) [Time Frame: 3 Months]
- Secondary Outcome Measures
Name Time Method 1. Change in Corneal thickness <br/ ><br>2. Intraocular Inflammation with Grade of Inflammation <br/ ><br>3. Corneal Clarity <br/ ><br>4. CV in cell size <br/ ><br>5. Cell area <br/ ><br>6. Number of cell analyzed <br/ ><br>7. Cell Hexagonality <br/ ><br>8. Adverse Event/complicationTimepoint: Baseline & 3 months