Clinical Evaluation of Toric Intraocular Lens Made by Aurolab

Phase 4

• Conditions: Astigmatism
• Interventions: Device: Experimental - Toric Intraocular lenses

• Registration Number: NCT01396616
• Lead Sponsor: Aurolab

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.

Study Timeline

• Status Verified: 2011-07
• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-17
• Study First Posted: 2011-07-19
• Study Start: 2011-08
• Last Update Submitted: 2013-01-07
• Last Update Posted: 2013-01-08
• Primary Completion: 2013-05
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Experimental - Toric Intraocular lenses	The enrolled subject will be implanted with Toric IOL manufactured by AuroLab

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Aravind Eye Hospital; 🇮🇳 Madurai, Tamilnadu, India