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

Phase 4

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

• Registration Number: CTRI/2023/03/050364
• 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) 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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, <br/ ><br>24 hours, 7 day, 30 day, 90 day post-operative and as and when occur]

Secondary Outcome Measures

Name	Time	Method
The Endothelial Cell Density Changes from pre-operative to 3 months post-operative for both OVD group. <br/ ><br>2 The grade of inflammation <br/ ><br>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. <br/ ><br>5 The frequency and proportion of monocular BCVA will be reported over time by visual acuity line. <br/ ><br>6 The frequency and proportion of monocular UCVA will be reported over time by visual acuity line. <br/ ><br>7 The change in corneal thickness from baselineTimepoint: intra-operativevisit,8-hours, <br/ ><br>24 hours, 7 day, 30 day, 90 day post-operative and as and when occur]