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| Name | Class |
|---|---|
| University of Alicante | OTHER |
| Instituto Universitario de OftalmobiologÃa Aplicada (Institute of Applied Ophthalmobiology) - IOBA | OTHER |
| Ministerio de EconomÃa y Competitividad, Spain | OTHER_GOV |
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This multicentre randomised controlled trial aimed to reduce the visual discomfort that patients implanted with trifocal diffractive intraocular lenses may experience after surgery. To this end, a visual training software (Optictrain) was developed in which Gabor patches were presented to the patient on a hand-held electronic device. Patients who met all inclusion criteria and consented to participate underwent half an hour of visual training per day for a period of 20 consecutive days remotely on a colourimetrically characterised Samsung Galaxy Tab A device on which the Optictrain software (n=30) or a placebo software (n=30), respectively, was pre-installed. Corrected and uncorrected near, intermediate and distance visual acuity (VA) and mesopic near and distance contrast sensitivity (CS) were measured monocularly and binocularly at two visits: during the first postoperative week (V0) and after 20 days of visual training with the assigned software (V1). The statistical analysis of the results obtained in the study has not yet been carried out.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Active Comparator | Half an hour of active visual training per day for a period of 20 consecutive days with the Optictrain software |
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| Control group | Sham Comparator | Half an hour of using a videogame without specific stimuli to improve visual performance (Fun Kid Racing 3.53 for Android) per day for a period of 20 consecutive days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of trifocal diffractive intraocular lenses | Procedure | Postsurgical monocular and binocular assessment of corrected and uncorrected near, intermediate and distance visual acuity and near and distance mesopic contrast sensitivity before and after the assigned vision training |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | Monocular and binocular corrected and uncorrected visual acuity under near, intermediate and distance conditions | During the first post-operative week and after 20 days of vision training with the randomly assigned software |
| Contrast sensitivity | Monocular and binocular mesopic contrast sensitivity under near and distance conditions | During the first post-operative week and after 20 days of vision training with the randomly assigned software |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, University of Valladolid | Valladolid | 47005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37464228 | Derived | Pinero DP, Maldonado-Lopez MJ, Molina-Martin A, Garcia-Sanchez N, Ramon ML, Rincon JL, Holgueras A, Arenillas JF, Planchuelo-Gomez A, Leal-Vega L, Coco-Martin MB. Randomised placebo-controlled clinical trial evaluating the impact of a new visual rehabilitation program on neuroadaptation in patients implanted with trifocal intraocular lenses. Int Ophthalmol. 2023 Nov;43(11):4035-4053. doi: 10.1007/s10792-023-02809-9. Epub 2023 Jul 18. |
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| ID | Term |
|---|---|
| D001766 | Blindness |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Experimental group vs control group
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| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |