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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Aurolab.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Aurolab Identifier:
First received: July 14, 2011
Last updated: January 7, 2013
Last verified: July 2011
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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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.


Ages Eligible for Study:   40 Years to 65 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01396616

Contact: Dr. Haripriya Aravind, MBBS., MS., +91 452 4356100 ext 161
Contact: Mr. Mohamed Hussain, M.Pharm +91 452 4356100 ext 364

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

Responsible Party: Aurolab Identifier: NCT01396616     History of Changes
Other Study ID Numbers: 1PN1011037
Study First Received: July 14, 2011
Last Updated: January 7, 2013

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases processed this record on September 19, 2017