Cataract
Conditions
Keywords
Lenses, Intraocular, Prospective Studies, Visual acuity, Clinical Trial
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.
Interventions
DEVICEIntraocular Lens
Phacoemulsification with in the bag implantation of the IOL
Sponsors
Aurolab
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity | 10days, 40 days, 150 days post operatively |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
India
Outcome results
None listed