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| Name | Class |
|---|---|
| Hospital Universitario La Fe | OTHER |
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This is a study to evaluate the 24 month postoperative incidence and intensity of posterior capsular opacity in patients submitted to cataract surgery and implanted with a hydrophobic monofocal IOL.
This study is a two-arm masked clinical evaluation study of incidence of PCO after successful bilateral cataract surgery with implantation of a monofocal IOL. Subjects will be assessed 24 months after IOL implantation. Clinical evaluations will include incidence of adverse events, patient satisfaction questionnaire, as well as measurements of visual performance, optical quality, presence and intensity of PCO, presence and intensity of IOL glistening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon Monofocal IOL | Patients bilaterally implanted with the Clareon monofocal IOL | ||
| Asqelio Monofocal IOL | Patients bilaterally implanted with the Asqelio monofocal IOL |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Posterior capsular opacity | Incidence of PCO | 24 months after IOL implantation |
| Intensity of Posterior capsular opacity | Intensity of PCO determined using LOCSIII Classification System | 24 months after IOL implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | Best corrected distance visual acuity in LogMAR units using the ETDRS chart | 1 month, 6 months, 12 months and 24 months after IOL implantation |
| Refraction | Residual refractive error in diopters determined objectively |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects submitted to non-traumatic cataract surgery in at least 1 eye at the Hospital La FĂ© of Valencia, Spain
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario y Politécnico la Fe | Valencia | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39781444 | Derived | Hervas-Ontiveros A, Espana-Gregori E, Fresno-Canada C, Butron-Ruiz R, Cervino A. Posterior Capsular Opacification and Glistening in Hydrophobic Monofocal Biaspheric Intraocular Lens Two Years After Implantation: A Case Control Study. J Ophthalmol. 2024 Dec 31;2024:3520219. doi: 10.1155/joph/3520219. eCollection 2024. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 1 month, 6 months, 12 months and 24 months after IOL implantation |
| Optical quality | Higher-order wavefront aberrations determined using a clinical wavefront analyzer | 24 months after IOL implantation |
| Incidence of Glistening | Incidence of IOL glistening | 24 months after IOL implantation |
| Intensity of Glistening | Intensity of IOL glistening | 24 months after IOL implantation |