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A Comparison of intra-operative efficiencies and surgical outcomes between two operating systems: the torsional (Ozil technology) versus transversal (EllipsFx technology) ultrasound systems

Phase 4
Conditions
Health Condition 1: H251- Age-related nuclear cataract
Registration Number
CTRI/2023/09/057312
Lead Sponsor
Dr Naren Shetty
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Age of patient between 50-75 years

2.Patients with senile cataract whose biometry fall within the normal/average category range of keratometry (41 to 46 D), axial lengths (21 to 26mm) and IOL powers (18 to 26D)

3.Nuclear sclerosis grades 2 & 3

4.Normal macula and peripheral retina

5.Normal transparent cornea

6.Normal intra ocular pressure

Exclusion Criteria

1.Age less than 50 or more than 75

2.Traumatic cataract/ Subluxated cataract/ Posterior Polar cataract

3.Floppy Iris Syndrome

4.Post Anti-VEGF injection/Post Uveitis Cataract

5.Presence of axial length more than 26 mm or less than 21 mm

6.Prior ocular surgeries

7.Presence of Corneal dystrophies/corneal scars/opacities and post corneal surgeries such as penetrating keratoplasty, LASIK etc

8.Presence of anterior chamber abnormalities like iris coloboma/lens coloboma, peripheral anterior synechiae or peripheral iridotomy.

9.Small pupil conditions such as pseudo exfoliation

10.Patients with pre-existing glaucoma

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Safety of the 2 operating platforms with respect to changes in corneal endotheliumTimepoint: Day 0, Surgery, Post op Day 1, Post op Day 30
Secondary Outcome Measures
NameTimeMethod
Comparison of wound architecture & post operative inflammationTimepoint: Day 0, Surgery, Post op Day 1, Post op Day 30
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