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This clinical trial is to study the digital method for eye lens to be placed during cataract surgery by comparing with the manual method

An Open-label, Prospective, Randomized, Multi-Center, Clinical Trial Designed to Evaluate the Clinical Outcomes with Digital Workflow Solution Versus Conventional Workflow Solution Refractive Outcomes Among Patients Undergoing Cataract Surgery with Toric Intraocular Lens - TORBI-CARIN-2024

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065250
Enrollment
80
Registered
2024-04-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: H252- Age-related cataract, morgagnian type Health Condition 2: H259- Unspecified age-related cataract

Interventions

Intervention1: Digital axis overlay for Toric IOL orientation: The CALLISTO® Eye within the digital cataract workflow allows for digital overlay of the axis to enable Toric IOL orientation inside the

Sponsors

Center for Application Research in India (CARIn) Carl Zeiss India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects with regular corneal astigmatism greater than 0.75D willing to undergo cataract extraction. Patient willing to undergo cataract surgery with implantation of an Toric intraocular lenses. Patient giving full and free consent for involvement in the study. Patient willing to come for follow up study visits and measurements.

Exclusion criteria

Exclusion criteria: Any ocular pathology or degeneration that could have impact on vision and/or a contradiction to Toric IOL implantation. Any surgical complication felt to in any way impact upon the quality of visual outcome. Any other comorbid conditions or risk factors that may affect the surgical procedure.

Design outcomes

Primary

MeasureTime frame
One-month postoperative refractionTimepoint: 1 week and 1 month

Secondary

MeasureTime frame
Uncorrected & best corrected visual acuity by log MAR visual acuity 1 month. IOL axis alignment, immediate postop, 1 day postop & 1 month postop.Timepoint: 1 week & 1 month.

Countries

India

Contacts

Public ContactT Vijay Bhaskar

Invitro Research Solutions Pvt. Ltd.

channa@ivrs.org.in6366947473

Outcome results

None listed

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