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

Status

Completed

Conditions

Intervention / Treatment

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

  • India
    • 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

36 years to 61 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
Device: Intraocular Lens
Phacoemulsification with in the bag implantation of the IOL
Other Names:
  • Aurovue, Model HP757SQ

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

Aurolab

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

Keywords

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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