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Consecutive comparative case series evaluating visual outcomes and patientreported satisfaction after bilateral cataract surgery with implantation of the same IOL type (standard monofocal, enhanced monofocal, or novel EDOF IOL). Outcomes assessed at 6 months included uncorrected visual acuity at distance, intermediate, and near; refraction; defocus curves; and questionnaires on halos, glare, and spectacle independence.
Patients undergoing bilateral phacoemulsification for age-related cataract received one of three IOLs in both eyes: Tecnis ZCB00 (monofocal), Tecnis Eyhance ICB00 (enhanced monofocal), or Asqelio EDOF ETLIO130C (EDOF). Follow-up examinations were performed at 1 day, 1 week, 1 month, 3 months, and 6 months. The 6-month assessment included monocular and binocular visual acuity at distance (6 m), intermediate (66 cm), and near (40 cm), manifest and objective refraction, binocular defocus curves (+1.00 D to -2.50 D in 0.50 D steps), and patient questionnaires (NEI-RQL-42 glare items; custom spectacle independence and satisfaction survey).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monofocal IOL | Tecnis ZCB00 (Johnson & Johnson Vision) | ||
| Enhanced monofocal IOL | Tecnis Eyhance ICB00 (Johnson & Johnson Vision) | ||
| EDOF IOL | Asqelio EDOF ETLIO130C (AST Products) |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Outcomes |
| 6 months |
| Patient satisfaction score | The patients were asked about their satisfaction with the refractive outcome, as used in International Multicenter Concerto Study as follows: How satisfied are you with your spectacle-free vision at far/intermediate/near distance? The answer choices ranged from 0 (not at all satisfied) to 10 (very satisfied). | postoperative 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity |
| 6 months |
| Objective refraction | Manifest and objective refraction (spherical equivalent) (Diyoptri) |
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Inclusion Criteria:
Exclusion Criteria:
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All sex, Ages: 45-75 years, Healthy Volunteers: No
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sakarya Yenikent State Hospital | Sakarya | Adapazarı | 54140 | Turkey (Türkiye) |
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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 | Feb 6, 2024 | Apr 21, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 6, 2022 | Mar 13, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| 6 months |
| Defocus curve | Binocular defocus curve performance (+1.00 D to -2.50 D) (diyoptri) | 6 months |
| Photic phenomena | Halo and glare scores (NEI-RQL-42 items 17 and 38; (0-100 scale) | 6 months |