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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

A comparison of intra-operative efficiencies and surgical outcomes between two operating systems:torsional (Ozil technology)versus transversal (EllipsFx technology)ultrasound systems- A prospective, randomized, comparative, single center study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057312
Enrollment
120
Registered
2023-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H251- Age-related nuclear cataract

Interventions

Intervention1: EllipsFx Technology: Transversal Ultrasound System 1. Screening Visit 2. Day of Surgery 3. Post Operative Day 1 4. Post Operative Day 30 Control Intervention1: OZIL Technology: Torsiona

Sponsors

Dr Naren Shetty
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Comparison of wound architecture & post operative inflammationTimepoint: Day 0, Surgery, Post op Day 1, Post op Day 30

Countries

India

Contacts

Public ContactDr Tejal

Narayana Nethralaya

narenshetty.27@gmail.com9900900204

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026