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| ID | Type | Description | Link |
|---|---|---|---|
| 47/2018 | Other Identifier | CEIm Grupo Hospitalario Quirónsalud-Catalunya |
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PURPOSE: To assess the correlation between the change in pupil diameter, age and depth of the anterior chamber after 3 months of cataract surgery both in photopic and mesopic conditions. And study the changes of the pupillary diameter at 3 months after surgery in the two light conditions
Healthy patients who are going to be operated on for cataracts are expected to take part in the study. If during the clinical study the minimum number of patients established in the protocol is exceeded, new samples will continue to be registered until the end of the established period.
The sample selection mechanism is by consecutive recruitment during the study period (in order of arrival at the medical office). Patients are operated bilaterally in a period not exceeding 15 days and it will get the variables of both eyes. A simple random sampling will be used for the choice of single eye data per patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pupil diameter before/after cataract | The investigators measure the pupil diameter before and after (3 months) cataract. Mesopic and photopic conditions |
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| Measure | Description | Time Frame |
|---|---|---|
| Pupil diameter | It took measurements of pupil diameter in mesopic and photopic conditions using pupillometer software of the Topolyzer Vario (Wavelight Laser Technologie AG). | Preoperatively and 3-months postoperatively |
| Anterior Chamber Depht | Anterior chamber depth was obtained with Pentacam® (Oculus Optikgeräte GmbH, Wetzlar, Germany). | Preoperatively |
| Age | It took the patient's age at the time of surgery | Preoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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The field in which the study will be carried out 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.
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| Name | Affiliation | Role |
|---|---|---|
| Enrique Ordiñaga-Monreal, OD | Clinica Oftalmologica TACIR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Oftalmológica TACIR | Barcelona | 08022 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25661135 | Background | Kanellopoulos AJ, Asimellis G, Georgiadou S. Digital pupillometry and centroid shift changes after cataract surgery. J Cataract Refract Surg. 2015 Feb;41(2):408-14. doi: 10.1016/j.jcrs.2014.05.049. | |
| 33549502 | Derived | Ordinaga-Monreal E, Castanera-Gratacos D, Castanera F, Fambuena-Muedra I, Vega F, Millan MS. Pupil size differences between female and male patients after cataract surgery. J Optom. 2022 Apr-Jun;15(2):179-185. doi: 10.1016/j.optom.2020.09.005. Epub 2021 Feb 3. |
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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 | Jun 21, 2018 | Feb 25, 2020 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 21, 2018 | Feb 25, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011681 | Pupil Disorders |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007905 | Lens Diseases |