SPECTACLE INDEPENDENCE AFTER IMPLANTATION OF TORIC IOL IN CATARACT PATIENTS

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2010/091/000302
• Date of registration: 10-08-2010
• Prospective Registration: No
• Primary sponsor: Alcon research Ltd
• Public title: SPECTACLE INDEPENDENCE AFTER IMPLANTATION OF TORIC IOL IN CATARACT PATIENTS
• Scientific title: Spectacle independence for distance vision after implantation of Toric IOL in cataract patients
• Date of first enrolment: 13-07-2010
• Target sample size: 146
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=1508
• Study type: Observational
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

China, Guyana, Taiwan

Contacts

• Name: Dr Abhay Vasavada
• Affiliation: Ila Devi IOl research centre

• Name: Dr Abhay Vasavada
• Affiliation: Ila Devi IOl research centre

Key inclusion & exclusion criteria

Inclusion criteria: 1. Fourty years of age or older

2.Had an age-related cataract and corneal astigmatism

3.Had cataract surgery using phacoemulsification with Toric IOL implantations in the posterior chamber bilaterally or unilaterally with fellow eye UCVA not less than 0.6(Decimal)

4.Had a Toric lens implanted in the eyes at least 3 month before the inclusion date for the last eye operated;

5.Signed a written consent for participation in this study
Exclusion criteria: 1.Had Toric lenses implanted during a clinical trial
2.Had complications during surgery which require wearing glasses
3.Had post-surgery infectious complications
4.Had refractive surgery before and after the Toric lens implantation (i.e. LASIK,LRI and PRK)
5.Had concomitant ocular diseases at the time of surgery deteriorating the visual acuity prognosis
6.Was unable to undertake personal interview (due to deafness or cognitive impairments for example)
7.Had any ocular or systemic conditions based on investigator?s judgment that may skew the study results
8.Currently participate in other clinical study


Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: NIL: NIL
Control Intervention1: NIL: NIL

Primary Outcome(s)

NILTimepoint: NIL

Secondary Outcome(s)

NILTimepoint: NIL

Secondary ID(s)

NIL

Source(s) of Monetary Support

Alcon Research Ltd

Ethics review

Status: Approved
Approval date: 24/06/2010
Contact:

Iladevi Cataract & IOL Research Center Ethics Committee