To evaluate and compare the performance & safety of two viscoelastic devices of varying concentrations in patient undergoing cataract surgery.

Phase 4

• Conditions: Health Condition 1: H251- Age-related nuclear cataract

• Registration Number: CTRI/2023/03/050365
• Lead Sponsor: Biotech Ophthalmics Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br/ ><br>2. Post-operative 24 hours ± 4 hours <br/ ><br>3. Post-operative 7 Days ± 2 days <br/ ><br>4. Post-operative 30 days ± 7 days <br/ ><br>5. Post-operative 90 days ± 14 days

Secondary Outcome Measures

Name	Time	Method
1.Intraocularpressure <br/ ><br>2) Changes in cell density of the corneal endothelium <br/ ><br>3) Intraocular Inflammation with Grade of Inflammation <br/ ><br>4) Corneal thickness (μm) <br/ ><br>5) Corneal ClarityTimepoint: 1. Post-operative 8 hours ± 2 hours <br/ ><br>2. Post-operative 24 hours ± 4 hours <br/ ><br>3. Post-operative 7 Days ± 2 days <br/ ><br>4. Post-operative 30 days ± 7 days <br/ ><br>5. Post-operative 90 days ± 14 days