Clinical Evaluation of Toric Intraocular Lens Made by Aurolab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-06-30

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.

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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.

Conditions

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Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

The enrolled subject will be implanted with Toric IOL manufactured by AuroLab

Group Type EXPERIMENTAL

Experimental - Toric Intraocular lenses

Intervention Type DEVICE

Toric Intraocular Lenses will be implenated with cataract patients having astigmatism

Interventions

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Experimental - Toric Intraocular lenses

Toric Intraocular Lenses will be implenated with cataract patients having astigmatism

Intervention Type DEVICE

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No