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First object is to compare square edge PMMA with round edge PMMA IOL where the materials are same. Next objective is to compare square edge PMMA IOL with Acrysof IOL where the materials are different
Cataract is the vision impairing disease characterized by gradual, progressive thickening of the lens. Posterior Capsular Opacification (PCO) remains the most frequent long term complication. This is initiated by the migration and proliferation of residual lens epithelial cells from the lens equator in the space between the posterior capsule and intraocular lens (IOL)
The combination of IOL material and a sharp edged design is effective in preventing PCO. Aurolab has developed 360 degree square edge IOL with polymethyl methacrylate (PMMA)
100 bilateral senile cataract patients are going to be recruited. First group of 50 patients will receive square edge PMMA in one eye and round edge PMMA in fellow eye. Another group of 50 patients will receive square edge PMMA in one eye and acrysof in fellow eye. PCO will be assessed during each follow up using EPCO software.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 A - Square edge PMMA IOL | Experimental | 50 patientes will recieve square edge PMMA IOL |
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| 1B | Active Comparator | In group 1, 50 eyes will receive round edge PMMA IOL |
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| 2A | Experimental | In group 2, 50 eyes will receive square edge PMMA IOL |
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| 2B | Active Comparator | In group 2, 50 eyes will receive acrysof IOL |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Square edge PMMA IOL | Device | Arm 1 A - Square edge PMMA IOL |
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| Measure | Description | Time Frame |
|---|---|---|
| PCO | 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haripriya Aravind, MBBS, MS | Aravind Eye Hospital, Madurai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aravind Eye Hospital | Madurai | Tamil Nadu | 625020 | India |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Round edge PMMA IOL | Device | Round edge PMMA IOL |
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| Acrysof IOL | Device | Acrysof IOL |
|
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| square Edge PMMA IOL | Device | Square edge PMMA intra ocular lens |
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| Square Edge PMMA IOL | Device | Square Edge PMMA IOL lens |
|