Aurolab Hydrophobic Foldable Intraocular Lens Study
Phase 4
Completed
- Conditions
- Cataract
- Interventions
- Device: Intraocular Lens
- Registration Number
- NCT00449267
- Lead Sponsor
- Aurolab
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Intraocular Lens -
- Primary Outcome Measures
Name Time Method Visual acuity 10days, 40 days, 150 days post operatively
- Secondary Outcome Measures
Name Time Method Refraction 10days, 40 days, 150 days post operatively Intraocular pressure 10days, 40 days, 150 days post operatively Corneal status 10days, 40 days, 150 days post operatively Iritis 10days, 40 days, 150 days post operatively IOL decentration 10days, 40 days, 150 days post operatively IOL tilt 10days, 40 days, 150 days post operatively IOL discoloration 10days, 40 days, 150 days post operatively IOL opacity 10days, 40 days, 150 days post operatively Cystoid macular oedema 10days, 40 days, 150 days post operatively Hypopyon 10days, 40 days, 150 days post operatively Endophthalmitis 10days, 40 days, 150 days post operatively Pupillary block 10days, 40 days, 150 days post operatively Retinal detachment 10days, 40 days, 150 days post operatively Status of anterior and posterior capsule 10days, 40 days, 150 days post operatively
Trial Locations
- Locations (1)
Aravind Eye Hospital
🇮🇳Madurai, Tamil Nadu, India