NCT01396616

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 8, 2013

Status Verified

July 1, 2011

Enrollment Period

1.8 years

First QC Date

July 14, 2011

Last Update Submit

January 7, 2013

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Refractive error correction

    150 days

Study Arms (1)

Single Arm

EXPERIMENTAL

The enrolled subject will be implanted with Toric IOL manufactured by AuroLab

Device: Experimental - Toric Intraocular lenses

Interventions

Experimental - Toric Intraocular lensesDEVICE

Toric Intraocular Lenses will be implenated with cataract patients having astigmatism

Single Arm

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 to 65
  • Senile cataract
  • Posterior Sub Capsular Cataract (PSCC)
  • Astigmatism 1.25 D or more
  • Residence within 100 kms of Madurai

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aravind Eye Hospital

Madurai, Tamil Nadu, 625020, India

RECRUITING

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Dr. SHIVKUMAR CHANDRASHEKAR, MBBS., MS.,

    HOD of IOL & Cataract clinic, Aravind Eye Hospital, Tirunelveli

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Haripriya Aravind, MBBS., MS.,

CONTACT

+91 452 4356100haripriya@aravind.org

Mr. Mohamed Hussain, M.Pharm

CONTACT

+91 452 4356100clinicalresearch@aravind.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 19, 2011

Study Start

August 1, 2011

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

January 8, 2013

Record last verified: 2011-07

Locations

IN(1)