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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Aurolab.
Recruitment status was  Recruiting
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

July 14, 2011
January 7, 2013
August 2011
May 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01396616 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Clinical Evaluation of Toric Intraocular Lens Made by Aurolab
Clinical Evaluation of Toric Intraocular Lens Made by Aurolab

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Astigmatism
Device: Experimental - Toric Intraocular lenses
Toric Intraocular Lenses will be implenated with cataract patients having astigmatism
Experimental: Single Arm
The enrolled subject will be implanted with Toric IOL manufactured by AuroLab
Intervention: Device: Experimental - Toric Intraocular lenses
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
June 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
40 Years to 65 Years
No
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
India
 
NCT01396616
1PN1011037
No
Aurolab
Aurolab
Not Provided
Principal Investigator: Dr. SHIVKUMAR CHANDRASHEKAR, MBBS., MS., HOD of IOL & Cataract clinic, Aravind Eye Hospital, Tirunelveli
Aurolab
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP