Astigmatism
Conditions
Brief summary
The purpose of this study is to measure visual acuity and Intraocular Lens (IOL) rotational stability after implantation of TORIC IOL and to assess the post operative complications after implantation of TORIC IOL.
Detailed description
Among available methods for treating astigmatism in cataract surgery, the implantation of toric IOLs is an emerging technology that shows promising results. Similar to implanting a one-piece acrylic lens, toric IOLs provide good distance vision and, in many patients, freedom from spectacles for distance vision. A low absolute residual refractive cylinder has been associated with the implantation of toric IOLs, and the safety profile for toric IOLs has been good. As improvements with regard to rotational stability and treatment and cylinder power range are made, toric IOLs will emerge as an effective, safe treatment option for correcting astigmatism during cataract surgery. Further, to evidence on the safety and efficacy of TORIC IOL for patients having cataract associated with astigmatism served as the basis for us to identify the published literature on the safety and efficacy of TORIC IOL implantation in the treatment of cataract associated with astigmatism, thus provide a background for the development of clinical investigation plan for the present study.
Interventions
DEVICEExperimental - Toric Intraocular lenses
Toric Intraocular Lenses will be implenated with cataract patients having astigmatism
Sponsors
Aurolab
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 40 to 65 * Senile cataract * Posterior Sub Capsular Cataract (PSCC) * Astigmatism 1.25 D or more * Residence within 100 kms of Madurai
Exclusion criteria
* Traumatic & Complicated cataract * Poor mydriasis * Amblyopia * Severe Pseudo exfoliation (PXF) * Dense posterior polar cataract (PPC) * One eyed patients * Uveitis * Corneal pathology / Scar * Retinal Pathology contributing to visual loss * Intraoperative complication like PC rupture, Zonular dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| vision improvement | 150 days | The visual acuity will be measured after iol implantation on 1 day, 10 days, 40 days and 150 days post operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Refractive error correction | 150 days | To measure the refraction error after IOL implantation on 1 day, 10 days, 40 days and 150 days post operatively |
Countries
India
Contacts
Primary ContactDr. Haripriya Aravind, MBBS., MS.,
Backup ContactMr. Mohamed Hussain, M.Pharm
Outcome results
None listed