Aurolab Hydrophobic Foldable Intraocular Lens Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of Hydrophobic Foldable Intraocular Lenses

Conditions
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Cataract

Intervention / Treatment
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* Device: Intraocular Lens


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Intraocular Lens<br>* Phacoemulsification with in the bag implantation of the IOL<br>* Other names: Aurovue, Model HP757SQ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 10days, 40 days, 150 days post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lenses, Intraocular, Prospective Studies, Visual acuity, Clinical Trial