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TORICIOL: Clinical Evaluation of Toric Intraocular Lens Made by Aurolab

Sponsor
Aurolab (Other)
Overall Status
Unknown status
CT.gov ID
NCT01396616
Collaborator
(none)
120
Enrollment
1
Location
1
Arm
22
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

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
  • 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
Anticipated Enrollment :
120 participants
Allocation:
N/A
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 :
Aug 1, 2011
Anticipated Primary Completion Date :
May 1, 2013
Anticipated Study Completion Date :
Jun 1, 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 [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 [150 days]

    To measure the refraction error after IOL implantation on 1 day, 10 days, 40 days and 150 days post operatively

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Aravind Eye Hospital Madurai Tamilnadu India 625020

Sponsors and Collaborators

  • Aurolab

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aurolab
ClinicalTrials.gov Identifier:
NCT01396616
Other Study ID Numbers:
  • 1PN1011037
First Posted:
Jul 19, 2011
Last Update Posted:
Jan 8, 2013
Last Verified:
Jul 1, 2011
Additional relevant MeSH terms:
Astigmatism

Study Results

No Results Posted as of Jan 8, 2013