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| ID | Type | Description | Link |
|---|---|---|---|
| 2019/65-OFT-CMT | Other Identifier | CEIm Grupo Hospitalario QuirĆ³nsalud-Catalunya |
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MAIN OBJECTIVE: To assess the influence of residual astigmatism on visual acuity in the different lens foci in patients operated on for cataracts with a trifocal intraocular lens implant.
SECONDARY OBJECTIVE: To study the influence of residual astigmatism on the visual quality of the patient in the far focus and to determine if there are differences of affectation in the two study groups.
It will be studied how small residual astigmatisms after cataract surgery degrade the visual acuity of patients in the three focal planes of trifocal IOLs. Not only VA will be studied, but also visual quality through contrast sensitivity curves.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trifocal IOL(Finevision IOL, PhysIOL) | We will divide the sample into two groups of patients depending on the IOL implanted First group: FineVision |
| |
| Trifocal toric IOL (Finevision Toric IOL, PhysIOL) | We will divide the sample into two groups of patients depending on the IOL implanted: Second group: FineVisionToric |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kind of trifocal IOL | Other | Patients will be divided between groups based on pre-surgery corneal astigmatism. Group FineVision is made up of patients with corneal astigmatism less than 1 D. Groups FineVision Toric is made up pf patients with corneal astigmatism more than 1.25 D |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual acuity will be measured at distance, intermediate distance (67 cm) and near (40 cm). Visual acuities will be obtained with logarithmic notation | 3 months following cataract surgery |
| Contrast Sensitivity Function (CSF) | Contrast sensitivity will be measured at far, intermediate distance (67 cm) and near (40 cm). | 3 months following cataract surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Differences between groups | Results will be compared between groups. | 3 months following cataract surgery |
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Inclusion Criteria:
Exclusion Criteria:
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The field in which it will carry out the study is a private medical centre. TACIR Ophthalmology clinic is located in the TEKNON Medical Center in the city of Barcelona. The study population will be the patients of the TACIR ophthalmology clinic who will be operated on cataracts and agree to take part in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enrique OrdiƱaga-Monreal, OD | Contact | 934179803 | e.ordinaga@clinicatacir.com |
| Name | Affiliation | Role |
|---|---|---|
| Enrique OrdiƱaga-Monreal, OD | Clinica Oftalmologica TACIR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica OftalmolĆ³gica TACIR | Recruiting | Barcelona | 08022 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 29, 2019 | May 11, 2020 |
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| SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 29, 2019 | May 11, 2020 | ICF_001.pdf |
| ID | Term |
|---|---|
| D058442 | Capsule Opacification |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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