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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01396616
Recruitment Status : Unknown
Verified July 2011 by Aurolab.
Recruitment status was:  Recruiting
First Posted : July 19, 2011
Last Update Posted : January 8, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Astigmatism Device: Experimental - Toric Intraocular lenses Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Toric Intraocular Lens Made by Aurolab
Study Start Date : August 2011
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : June 2013
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. vision improvement [ Time Frame: 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 :
  1. Refractive error correction [ Time Frame: 150 days ]
    To measure the refraction error after IOL implantation on 1 day, 10 days, 40 days and 150 days post operatively


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT01396616     History of Changes
Other Study ID Numbers: 1PN1011037
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: July 2011

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases