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To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by Aurolab.
Cataract till today remains the most common yet treatable cause of blindness accounting for more than 50% of blindness and visual impairment in the developing world. One of the most important features of a blade for cataract surgery is its predictable and repeatable behavior. The surgeon repeatedly and reliably needs to create similar tunnels of the proper length. Aurolab is producing surgical blades (Aurosleek) intended for making incision in cataract surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aurosleek blades | Patients having cataract will undergo surgery by using Aurosleek blades |
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| Measure | Description | Time Frame |
|---|---|---|
| Physioclinical Characters | Assessment of physio-clinical characteristics of surgical blade such as handling of the blade, sharpness and smoothness of blade. Handling of the surgical blade will be assessed in grades of difficult to handle,easy to handle and very easy to handle intraoperatively. Sharpness and smoothness of the blade will be rated as poor or optimum while performing cataract surgery. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post operative complications | The frequency and occurrence of post operative complications such as rhexis tear, posterior capsular rupture, severe corneal edema, severe iritis and anterior vitrectomy. Post operative complications occurrence due to surgical blade will be observed and graded as none or mild or moderate or severe at surgery and post operative 30 days. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing cataract surgery would be included in this observational study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karthikumar S, M.Pharm | Contact | 04523096100 | 228 | crd@aurolab.com |
| Name | Affiliation | Role |
|---|---|---|
| Neeraj Kumar Agrawal, MS | Medical Officer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aravind Eye Hospital | Recruiting | 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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