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Aurolab Hydrophobic Foldable Intraocular Lens Study

This study has been completed.
Sponsor:
Information provided by:
Aurolab
ClinicalTrials.gov Identifier:
NCT00449267
First received: March 17, 2007
Last updated: February 10, 2009
Last verified: February 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Hydrophobic Foldable Intraocular Lenses

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Aurolab:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 10days, 40 days, 150 days post operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Refraction [ Time Frame: 10days, 40 days, 150 days post operatively ] [ Designated as safety issue: No ]
  • Intraocular pressure [ Time Frame: 10days, 40 days, 150 days post operatively ] [ Designated as safety issue: Yes ]
  • Corneal status [ Time Frame: 10days, 40 days, 150 days post operatively ] [ Designated as safety issue: Yes ]
  • Iritis [ Time Frame: 10days, 40 days, 150 days post operatively ] [ Designated as safety issue: Yes ]
  • IOL decentration [ Time Frame: 10days, 40 days, 150 days post operatively ] [ Designated as safety issue: No ]
  • IOL tilt [ Time Frame: 10days, 40 days, 150 days post operatively ] [ Designated as safety issue: No ]
  • IOL discoloration [ Time Frame: 10days, 40 days, 150 days post operatively ] [ Designated as safety issue: No ]
  • IOL opacity [ Time Frame: 10days, 40 days, 150 days post operatively ] [ Designated as safety issue: No ]
  • Cystoid macular oedema [ Time Frame: 10days, 40 days, 150 days post operatively ] [ Designated as safety issue: Yes ]
  • Hypopyon [ Time Frame: 10days, 40 days, 150 days post operatively ] [ Designated as safety issue: Yes ]
  • Endophthalmitis [ Time Frame: 10days, 40 days, 150 days post operatively ] [ Designated as safety issue: Yes ]
  • Pupillary block [ Time Frame: 10days, 40 days, 150 days post operatively ] [ Designated as safety issue: Yes ]
  • Retinal detachment [ Time Frame: 10days, 40 days, 150 days post operatively ] [ Designated as safety issue: Yes ]
  • Status of anterior and posterior capsule [ Time Frame: 10days, 40 days, 150 days post operatively ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Haripriya Aravind, Aravind Eye Hospital
ClinicalTrials.gov Identifier: NCT00449267     History of Changes
Other Study ID Numbers: 1PN1010614
Study First Received: March 17, 2007
Last Updated: February 10, 2009
Health Authority: India: Ministry of Health

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

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013