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This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. Twenty patients (20) were enrolled in this study 10 patients in each group. It was designed for comparison of uncorrected and best corrected distance and intermediate vision in patients whom implanted with monofocal Tecnis Eyhance or Tecnis 1-piece IOLs.
Purpose To determine the Uncorrected and best-corrected distance, and intermediate visual acuity in a new innovative monofocal intraocular lens compared with standard monofocal lens.
Methods This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. 40 eyes of Twenty patients (20) were enrolled in this study, patients who are candidates for cataract extraction by phacoemulsification were included in this study and underwent thorough preoperative examination and post-operative evaluation at 3 months after the 2nd eye operation, of distance, intermediate, near add, contrast sensitivity and incidence of photic phenomena using a printed questionnaire for evaluating this incidence and binocular defocus curves were analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eyhance intraocular lens | Active Comparator | 10 patients bilaterally implanted with Eyhance intraocular lens |
|
| Tecnis 1 piece intraocular lens | Active Comparator | 10 patients bilaterally implanted with Tecnis 1 piece intraocular lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phacoemulsification | Procedure | cataract extraction followed by bilateral implantation of Eyhance intraocular lens in 10 patients and bilateral implantation of Tecnis 1 piece IOL in 10 patients |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected and best-corrected distance, and intermediate visual acuity. | Distance visual acuities were examined by ETDRS chart and intermediate and near visual acuity by Jaeger chart at 66 cm and 33 cm respectively.Measured values of the visual acuity were expressed in decimal values and converted to logMAR values. | 3 months post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast sensitivity | Contrast sensitivity was measured using Pelli Robson illuminated chart at 1m | 3 months post operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| yehia Salaheldin, PhD | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasraliany Hospital | Giza | 11555 | Egypt |
the data of the patients are kept in files with the principal investigator
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 2, 2022 | Sep 2, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D018918 | Phacoemulsification |
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D059708 | Ultrasonic Surgical Procedures |
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This is a prospective comparative interventional clinical study,
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| monofocal intraocular lens implantation | Procedure | implantation of monofocal intraocular lens in the capsular bag at the end of phacoemulsification surgery |
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