Back to resultsClinical Evaluation of Toric Intraocular Lens Made by Aurolab (TORICIOL)
Primary Purpose
Astigmatism
Status
Unknown status
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Experimental - Toric Intraocular lenses
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism
Eligibility Criteria
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
Sites / Locations
- Aravind Eye HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
The enrolled subject will be implanted with Toric IOL manufactured by AuroLab
Outcomes
Primary Outcome Measures
vision improvement
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
To measure the refraction error after IOL implantation on 1 day, 10 days, 40 days and 150 days post operatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01396616
Brief Title
Clinical Evaluation of Toric Intraocular Lens Made by Aurolab
Acronym
TORICIOL
Official Title
Clinical Evaluation of Toric Intraocular Lens Made by Aurolab
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurolab
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
The enrolled subject will be implanted with Toric IOL manufactured by AuroLab
Intervention Type
Device
Intervention Name(s)
Experimental - Toric Intraocular lenses
Intervention Description
Toric Intraocular Lenses will be implenated with cataract patients having astigmatism
Primary Outcome Measure Information:
Title
vision improvement
Description
The visual acuity will be measured after iol implantation on 1 day, 10 days, 40 days and 150 days post operatively
Time Frame
150 days
Secondary Outcome Measure Information:
Title
Refractive error correction
Description
To measure the refraction error after IOL implantation on 1 day, 10 days, 40 days and 150 days post operatively
Time Frame
150 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Haripriya Aravind, MBBS., MS.,
Phone
+91 452 4356100
Ext
161
Email
haripriya@aravind.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mr. Mohamed Hussain, M.Pharm
Phone
+91 452 4356100
Ext
364
Email
clinicalresearch@aravind.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. SHIVKUMAR CHANDRASHEKAR, MBBS., MS.,
Organizational Affiliation
HOD of IOL & Cataract clinic, Aravind Eye Hospital, Tirunelveli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aravind Eye Hospital
City
Madurai
State/Province
Tamilnadu
ZIP/Postal Code
625020
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Haripriya Aravind, MBBS., MS
Phone
+91 452 4356100
Ext
161
Email
drharipriya@aravind.org
First Name & Middle Initial & Last Name & Degree
Mrs. Kamatchi Kannan, BA
Phone
+91 452 4356100
Ext
364
Email
clinicaltrials@aravind.org
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Toric Intraocular Lens Made by Aurolab
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