Clinical Evaluation of Toric Intraocular Lens Made by Aurolab

Astigmatism Clinical Trial

— TORICIOL  

Official title:

Clinical Evaluation of Toric Intraocular Lens Made by Aurolab

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01396616
• Other study ID #: 1PN1011037
• Status: Unknown status
• Phase: Phase 4
• First received: July 14, 2011
• Last updated: January 7, 2013
• Start date: August 2011
• Est. completion date: June 2013

Study information

• Verified date: July 2011
• Source: Aurolab
• Contact: Dr. Haripriya Aravind, MBBS., MS.,
• Phone: +91 452 4356100
• Email: haripriya[@]aravind.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 120
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Experimental - Toric Intraocular lenses
Toric Intraocular Lenses will be implenated with cataract patients having astigmatism

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai	Tamilnadu

Sponsors (1)

Lead Sponsor	Collaborator
Aurolab

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vision improvement	The visual acuity will be measured after iol implantation on 1 day, 10 days, 40 days and 150 days post operatively	150 days
Secondary	Refractive error correction	To measure the refraction error after IOL implantation on 1 day, 10 days, 40 days and 150 days post operatively	150 days