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A comparison of intra-operative effeciencies and surgical outcomes between two operating systems-the torsional (Ozil Technology) versus transversal (EllipsFx technology) ultrasound systems: a prospective, randomized, comparative, double masked , single centre study

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042832
Enrollment
196
Registered
2022-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: H259- Unspecified age-related cataract Health Condition 2: H259- Unspecified age-related cataract

Interventions

Intervention1: ELLIPSFX Technology: Transversal Ultrasound system 1. Screening Visit 2. Day of Surgery 3. Post op Day 1 4. Post op Week 4 Control Intervention1: OZIL Technology: Torsional Ultrsound s

Sponsors

Dr Naren Shetty
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age of patient between 40-70 years 2.Cataract patients whose biometry fall in the normal average category range of keratometry (41 to 46 D), axial lengths (21 to 25mm) and IOL powers (19 to 26D) 3.Nuclear sclerosis grades 1 to 4, posterior subcapsular cataracts and cortical cataracts. 4.Normal macula and peripheral retina 5.Normal intraocular pressure

Exclusion criteria

Exclusion criteria: 1.Age less than 40 or more than 70 2.Traumatic cataract/ Subluxated cataract 3.Posterior Polar cataract 4.Floppy Iris Syndrome 5.Post Anti-VEGF injection 6.Post Uveitis Cataract 7.Presence of axial length more than 25 mm or less than 21 mm. 8.Presence of Corneal dystrophies/corneal scars/opacities 9.Presence of anterior chamber abnormalities like iris coloboma/lens coloboma, peripheral anterior synechiae or peripheral iridotomy. 10.Status post corneal surgeries such as penetrating keratoplasty, LASIK etc 11.Small pupil conditions such as pseudo exfoliation

Design outcomes

Primary

MeasureTime frame
Safety of the 2 operating platforms with respect to changes in corneal endotheliumTimepoint: 1. Screening Visit 2. Day of Surgery 3. Post op Day 1 4. Post op Week 4

Secondary

MeasureTime frame
Comparison of wound architecture and post operative inflammationTimepoint: 1. Screening Visit 2. Day of Surgery 3. Post op Day 1 4. Post op Week 4

Countries

India

Contacts

Public ContactDr Hemamalini

Narayana Nethralaya

drhemasrinath@gmail.com9845534833

Outcome results

None listed

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