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A single-center, Investigator Initiated study to check the Visual outcomes and Patient satisfaction after implantation of Vivity intra ocular lens in patients with mild irregular Astigmatism.

A single-center, Prospective, Investigator Initiated, Observational study to evaluate the Visual outcomes and Patient satisfaction after AcrySofVivity IOL implantation in patients with mild irregular Astigmatism. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/09/057797
Enrollment
30
Registered
2023-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: H538- Other visual disturbances

Interventions

Intervention1: None: Not Applicable Control Intervention1: None: Not Applicable

Sponsors

Dr Agarwal Eye Hospital Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult subjects 45 years or older with the normal axial length category (22-25mm) having uncomplicated age-related cataracts and undergoing standard cataract surgery procedure. 2. The subject is willing and able to provide informed consent personally or by a legal representative. 3. Subjects with mild irregular corneal astigmatism defined as mean keratometry values not higher than 47 D, Keratoconus Index (KI) showing Superior-Inferior Asymmetry not higher than 1.4 D, and Surface Regularity Index (SRI) between 0.56 and 1.55. Magnitude of astigmatism 0.0D to 4. Central corneal thickness between 520um to 560um.

Exclusion criteria

Exclusion criteria: 1. Adult subjects 45 years or older with the normal axial length category (22-25mm) having uncomplicated age-related cataracts and undergoing standard cataract surgery procedure. 2. The subject is willing and able to provide informed consent personally or by a legal representative. 3. Subjects with mild irregular corneal astigmatism defined as mean keratometry values not higher than 47 D, Keratoconus Index (KI) showing Superior-Inferior Asymmetry not higher than 1.4 D, and Surface Regularity Index (SRI) between 0.56 and 1.55. Magnitude of astigmatism 0.0D to 4. Central corneal thickness between 520um to 560um.

Design outcomes

Primary

MeasureTime frame
Monocular BCDVA postoperatively at 3 monthTimepoint: 3 month—

Secondary

MeasureTime frame
1.Monocular UDVA, UIVA, UNVA postoperatively 2.Monocular DCIVA, DCNVA postoperatively 3. Spectacle independence-Patient-Reported Spectacle Independence Questionnaire (PRSIQ) 4. Patient satisfaction questionnaire (VF-14QOL) Timepoint: 3 month—

Countries

India

Contacts

Public ContactDr Vinod Gyanchandani

Dr. Agarwals Eye Hospital

agarwal_ashvin@dragarwal.com9840430100

Outcome results

None listed

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