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Aurolab Hydrophobic Foldable Intraocular Lens Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00449267
First Posted: March 20, 2007
Last Update Posted: February 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aurolab
  Purpose
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.

Condition Intervention Phase
Cataract Device: Intraocular Lens Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Hydrophobic Foldable Intraocular Lenses

Resource links provided by NLM:


Further study details as provided by Aurolab:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 10days, 40 days, 150 days post operatively ]

Secondary Outcome Measures:
  • Refraction [ Time Frame: 10days, 40 days, 150 days post operatively ]
  • Intraocular pressure [ Time Frame: 10days, 40 days, 150 days post operatively ]
  • Corneal status [ Time Frame: 10days, 40 days, 150 days post operatively ]
  • Iritis [ Time Frame: 10days, 40 days, 150 days post operatively ]
  • IOL decentration [ Time Frame: 10days, 40 days, 150 days post operatively ]
  • IOL tilt [ Time Frame: 10days, 40 days, 150 days post operatively ]
  • IOL discoloration [ Time Frame: 10days, 40 days, 150 days post operatively ]
  • IOL opacity [ Time Frame: 10days, 40 days, 150 days post operatively ]
  • Cystoid macular oedema [ Time Frame: 10days, 40 days, 150 days post operatively ]
  • Hypopyon [ Time Frame: 10days, 40 days, 150 days post operatively ]
  • Endophthalmitis [ Time Frame: 10days, 40 days, 150 days post operatively ]
  • Pupillary block [ Time Frame: 10days, 40 days, 150 days post operatively ]
  • Retinal detachment [ Time Frame: 10days, 40 days, 150 days post operatively ]
  • Status of anterior and posterior capsule [ Time Frame: 10days, 40 days, 150 days post operatively ]

Enrollment: 120
Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: Intraocular Lens
Phacoemulsification with in the bag implantation of the IOL
Other Name: Aurovue, Model HP757SQ

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449267


Locations
India
Aravind Eye Hospital
Madurai, Tamil Nadu, India, 625020
Sponsors and Collaborators
Aurolab
Investigators
Principal Investigator: Haripriya Aravind, MBBS, MS Aravind Eye Hospital, Madurai
  More Information

Responsible Party: Dr. Haripriya Aravind, Aravind Eye Hospital
ClinicalTrials.gov Identifier: NCT00449267     History of Changes
Other Study ID Numbers: 1PN1010614
First Submitted: March 17, 2007
First Posted: March 20, 2007
Last Update Posted: February 11, 2009
Last Verified: February 2009

Keywords provided by Aurolab:
Lenses, Intraocular
Prospective Studies
Visual acuity
Clinical Trial

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases