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

This study is currently recruiting participants.
Verified July 2011 by Aurolab
Sponsor:
Information provided by (Responsible Party):
Aurolab
ClinicalTrials.gov Identifier:
NCT01396616
First received: July 14, 2011
Last updated: January 7, 2013
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Astigmatism
 Device: Experimental - Toric Intraocular lenses
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Toric Intraocular Lens Made by Aurolab

Further study details as provided by Aurolab:

Primary Outcome Measures:
  • vision improvement [ Time Frame: 150 days ] [ Designated as safety issue: No ]
    The visual acuity will be measured after iol implantation on 1 day, 10 days, 40 days and 150 days post operatively


Secondary Outcome Measures:
  • Refractive error correction [ Time Frame: 150 days ] [ Designated as safety issue: No ]
    To measure the refraction error after IOL implantation on 1 day, 10 days, 40 days and 150 days post operatively


Estimated Enrollment: 120
Study Start Date: August 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396616

Contacts
Contact: Dr. Haripriya Aravind, MBBS., MS., +91 452 4356100 ext 161 haripriya@aravind.org
Contact: Mr. Mohamed Hussain, M.Pharm +91 452 4356100 ext 364 clinicalresearch@aravind.org

Locations
India
Aravind Eye Hospital Recruiting
Madurai, Tamilnadu, India, 625020
Contact: Dr. Haripriya Aravind, MBBS., MS     +91 452 4356100 ext 161     drharipriya@aravind.org    
Contact: Mrs. Kamatchi Kannan, BA     +91 452 4356100 ext 364     clinicaltrials@aravind.org    
Sponsors and Collaborators
Aurolab
Investigators
Principal Investigator: Dr. SHIVKUMAR CHANDRASHEKAR, MBBS., MS., HOD of IOL & Cataract clinic, Aravind Eye Hospital, Tirunelveli
  More Information

No publications provided

Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT01396616     History of Changes
Other Study ID Numbers: 1PN1011037
Study First Received: July 14, 2011
Last Updated: January 7, 2013
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013