Clinical Evaluation of Toric Intraocular Lens Made by Aurolab

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of Toric Intraocular Lens Made by Aurolab

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Experimental - Toric Intraocular lenses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>The enrolled subject will be implanted with Toric IOL manufactured by AuroLab | Device: Experimental - Toric Intraocular lenses<br>* Toric Intraocular Lenses will be implenated with cataract patients having astigmatism<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vision improvement | The visual acuity will be measured after iol implantation on 1 day, 10 days, 40 days and 150 days post operatively | 150 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive error correction | To measure the refraction error after IOL implantation on 1 day, 10 days, 40 days and 150 days post operatively | 150 days |