Correlation of Pupillary Diameter Changewith Age and Anterior Chamber Depth After Cataract Surgery

NCT ID: NCT04286646

Last Updated: 2020-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-20

Study Completion Date

2019-12-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Pupillary Disorders

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Pupil diameter before/after cataract

The investigators measure the pupil diameter before and after (3 months) cataract. Mesopic and photopic conditions

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Both sexes with age equal to or greater than 45 years
* Diagnosed cataract N1, C1, P1 or worse in some eye.
* Patients who will be operated on both eyes.
* Patients who have not been diagnosed with diabetes mellitus.
* Patients who have given their informed consent to take part in the study.

Exclusion Criteria

* Age under 45 years.
* Patients with anisocoria, neurological disorders, diagnosed with diabetes mellitus, glaucoma or another eye disease.
* Patients with complications during and after cataract surgery.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinica Oftalmologica TACIR

OTHER

Sponsor Role lead

Responsible Party

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Enrique Ordiñaga-Monreal, OD, MSc

Clinical Optometrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enrique Ordiñaga-Monreal, OD

Role: PRINCIPAL_INVESTIGATOR

Clinica Oftalmologica TACIR

Locations

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Clinica Oftalmológica TACIR

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 25661135 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33549502 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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47/2018

Identifier Type: OTHER

Identifier Source: secondary_id

EC022018

Identifier Type: -

Identifier Source: org_study_id

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