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Completed

NCT Number: NCT00449267

Aurolab Hydrophobic Foldable Intraocular Lens Study

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aravind Eye Hospital

Madurai, Tamil Nadu, 625020, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraocular lens

Device

Phacoemulsification with in the bag implantation of the IOL

Other names: Aurovue, Model HP757SQ

Primary outcomes

  1. Visual acuity

    Time frame: 10days, 40 days, 150 days post operatively

Secondary outcomes

  1. Refraction

    Time frame: 10days, 40 days, 150 days post operatively

  2. Intraocular pressure

    Time frame: 10days, 40 days, 150 days post operatively

  3. Corneal status

    Time frame: 10days, 40 days, 150 days post operatively

  4. Iritis

    Time frame: 10days, 40 days, 150 days post operatively

  5. IOL decentration

    Time frame: 10days, 40 days, 150 days post operatively

  6. IOL tilt

    Time frame: 10days, 40 days, 150 days post operatively

  7. IOL discoloration

    Time frame: 10days, 40 days, 150 days post operatively

  8. IOL opacity

    Time frame: 10days, 40 days, 150 days post operatively

  9. Cystoid macular oedema

    Time frame: 10days, 40 days, 150 days post operatively

  10. Hypopyon

    Time frame: 10days, 40 days, 150 days post operatively

  11. Endophthalmitis

    Time frame: 10days, 40 days, 150 days post operatively

  12. Pupillary block

    Time frame: 10days, 40 days, 150 days post operatively

  13. Retinal detachment

    Time frame: 10days, 40 days, 150 days post operatively

  14. Status of anterior and posterior capsule

    Time frame: 10days, 40 days, 150 days post operatively

Sponsors and collaborators

Lead sponsor

Aurolab

Other

Registry information

Official study title

Clinical Evaluation of Hydrophobic Foldable Intraocular Lenses

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 20, 2007
Registry last updated
Feb 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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