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Aurolab Hydrophobic Foldable Intraocular Lens Study

This study has been completed.
Information provided by:
Aurolab Identifier:
First received: March 17, 2007
Last updated: February 10, 2009
Last verified: February 2009
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
Device: Intraocular Lens
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00449267

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

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

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

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases processed this record on April 27, 2017