- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00449267
Aurolab Hydrophobic Foldable Intraocular Lens Study
February 10, 2009 updated by: Aurolab
Clinical Evaluation of Hydrophobic Foldable Intraocular Lenses
The purpose of this study is to evaluate whether hydrophobic intraocular lenses manufactured by aurolab are safe and effective in the surgical treatment of cataract.
Study Overview
Detailed Description
Hydrophobic as the name suggests is fear for water.
Hydrophobic foldable IOLs are made from acrylic material.
Aurolab has developed its own hydrophobic acrylic material.
This material has been subjected to several biocompatibility studies and it has proved itself to be biocompatible.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tamil Nadu
-
Madurai, Tamil Nadu, India, 625020
- Aravind Eye Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 40 to 65 years
- Senile Cataract
- Posterior Subcapsular Cataract (PSCC)
Exclusion Criteria:
- Obviously debilitated patients
- Cardiac and other serious illness
- Diabetic Patients
- Traumatic cataract
- Complicated cataract
- Congenital cataract
- Drug induced cataract
- Shallow anterior chamber
- Poor mydriasis
- Amblyopia
- Pseudo exfoliation (PXF)
- Dense posterior polar cataract (PPC)
- One eyed patients
- Glaucoma
- Uveitis
- Corneal Pathology
- Retinal Pathology
- Intra operative complications like PC rupture, Zonular dialysis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Phacoemulsification with in the bag implantation of the IOL
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual acuity
Time Frame: 10days, 40 days, 150 days post operatively
|
10days, 40 days, 150 days post operatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Refraction
Time Frame: 10days, 40 days, 150 days post operatively
|
10days, 40 days, 150 days post operatively
|
Intraocular pressure
Time Frame: 10days, 40 days, 150 days post operatively
|
10days, 40 days, 150 days post operatively
|
Corneal status
Time Frame: 10days, 40 days, 150 days post operatively
|
10days, 40 days, 150 days post operatively
|
Iritis
Time Frame: 10days, 40 days, 150 days post operatively
|
10days, 40 days, 150 days post operatively
|
IOL decentration
Time Frame: 10days, 40 days, 150 days post operatively
|
10days, 40 days, 150 days post operatively
|
IOL tilt
Time Frame: 10days, 40 days, 150 days post operatively
|
10days, 40 days, 150 days post operatively
|
IOL discoloration
Time Frame: 10days, 40 days, 150 days post operatively
|
10days, 40 days, 150 days post operatively
|
IOL opacity
Time Frame: 10days, 40 days, 150 days post operatively
|
10days, 40 days, 150 days post operatively
|
Cystoid macular oedema
Time Frame: 10days, 40 days, 150 days post operatively
|
10days, 40 days, 150 days post operatively
|
Hypopyon
Time Frame: 10days, 40 days, 150 days post operatively
|
10days, 40 days, 150 days post operatively
|
Endophthalmitis
Time Frame: 10days, 40 days, 150 days post operatively
|
10days, 40 days, 150 days post operatively
|
Pupillary block
Time Frame: 10days, 40 days, 150 days post operatively
|
10days, 40 days, 150 days post operatively
|
Retinal detachment
Time Frame: 10days, 40 days, 150 days post operatively
|
10days, 40 days, 150 days post operatively
|
Status of anterior and posterior capsule
Time Frame: 10days, 40 days, 150 days post operatively
|
10days, 40 days, 150 days post operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Haripriya Aravind, MBBS, MS, Aravind Eye Hospital, Madurai
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
March 17, 2007
First Submitted That Met QC Criteria
March 19, 2007
First Posted (Estimate)
March 20, 2007
Study Record Updates
Last Update Posted (Estimate)
February 11, 2009
Last Update Submitted That Met QC Criteria
February 10, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1PN1010614
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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