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.
- Conditions
- Health Condition 1: H538- Other visual disturbances
- Registration Number
- CTRI/2023/09/057797
- Lead Sponsor
- Dr Agarwal Eye Hospital Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 <-0.75D only.
4.Central corneal thickness between 520um to 560um.
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 <-0.75D only.
4.Central corneal thickness between 520um to 560um.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Monocular BCDVA postoperatively at 3 monthTimepoint: 3 month
- Secondary Outcome Measures
Name Time Method 1.Monocular UDVA, UIVA, UNVA postoperatively <br/ ><br>2.Monocular DCIVA, DCNVA postoperatively <br/ ><br> <br/ ><br>3. Spectacle independence-Patient-Reported Spectacle Independence Questionnaire (PRSIQ) <br/ ><br>4. Patient satisfaction questionnaire (VF-14QOL) <br/ ><br>Timepoint: 3 month