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Checking visualization and comfort during eye surgery

Comparison of ease of visualization and comfort of the surgeon during phacoemulsification surgery using NGENUITY�® 3D Visualization System versus Standard Ocular Microscope(SOM)study.

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/12/038683
Enrollment
224
Registered
2021-12-16
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: H258- Other age-related cataract

Interventions

Intervention1: NGENUITY�® 3D Visualization System: The NGENUITY�® 3D Visualization System is a workstation with a 3D stereoscopic, highdefinition digital video camera which provides a magnified st

Sponsors

Narayana Nethrayala
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Age of patient between 40-70 years -Routine cataract phacoemulsification surgery and axial length between 21.00 mm to 25.00 mm -Nuclear Sclerosis grade 2 and above with or without posterior subcapsular cataract and or cortical cataract -Normal foveal contour -Normal transparent cornea

Exclusion criteria

Exclusion criteria: - Age less than 40 or more than 70 - Traumatic cataract/ Subluxated cataract - Posterior Polar cataract - Floppy Iris Syndrome - Post Anti-Vegf injection - Post Uveitis Cataract - Presence of axial length more than 25 mm or less than 21 mm. - Presence of Corneal dystrophies/corneal scars/opacities - Presence of anterior chamber abnormalities like iris coloboma/lens coloboma, peripheral anterior synechiae or peripheral iridotomy

Design outcomes

Primary

MeasureTime frame
the ease of visualisation of the surgeon while doing phacoemulsification procedureTimepoint: During surgery visit- On a scale of 1-5 ,1 being not easy to visualise at all, to 5 being very easy to visualise

Secondary

MeasureTime frame
- The presence or absence of corneal oedema - Presence of flare and anterior chamber cells - Ease of visualisation during capsulorrhexis -Ease of visualisation during Irrigation aspiration - Ease of visualisation during IOL insertion Timepoint: - On the first postoperative day - On the first postoperative day - During surgery visit - During surgery visit - During surgery visit

Countries

India

Contacts

Public ContactDr Sriharsha N

Narayana Nethralaya

crc1@narayananethralaya.com09900900204

Outcome results

None listed

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