Clinical Evaluation of Toric Intraocular Lens Made by Aurolab (TORICIOL)

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.

Study Overview

• Status: Unknown
• Conditions: Astigmatism
• Intervention / Treatment: Device: Experimental - Toric Intraocular lenses

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Tamilnadu
    • Madurai, Tamilnadu, India, 625020
      • Recruiting
      • Aravind Eye Hospital
      • Contact: Dr. Haripriya Aravind, MBBS., MS; Phone Number: 161 +91 452 4356100; Email: drharipriya@aravind.org
      • Contact: Mrs. Kamatchi Kannan, BA; Phone Number: 364 +91 452 4356100; Email: clinicaltrials@aravind.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aurolab
• Investigators: Principal Investigator: Dr. SHIVKUMAR CHANDRASHEKAR, MBBS., MS.,, HOD of IOL & Cataract clinic, Aravind Eye Hospital, Tirunelveli

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: July 14, 2011
• First Submitted That Met QC Criteria: July 17, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Estimate): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 7, 2013
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: 1PN1011037