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Clinical Trials/NCT04286646
NCT04286646
Completed
Not Applicable

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

Clinica Oftalmologica TACIR1 site in 1 country55 target enrollmentMay 20, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pupillary Disorders
Sponsor
Clinica Oftalmologica TACIR
Enrollment
55
Locations
1
Primary Endpoint
Anterior Chamber Depht
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
May 20, 2018
End Date
December 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Clinica Oftalmologica TACIR
Responsible Party
Principal Investigator
Principal Investigator

Enrique Ordiñaga-Monreal, OD, MSc

Clinical Optometrist

Clinica Oftalmologica TACIR

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Anterior Chamber Depht

Time Frame: Preoperatively

Anterior chamber depth was obtained with Pentacam® (Oculus Optikgeräte GmbH, Wetzlar, Germany).

Pupil diameter

Time Frame: Preoperatively and 3-months postoperatively

It took measurements of pupil diameter in mesopic and photopic conditions using pupillometer software of the Topolyzer Vario (Wavelight Laser Technologie AG).

Age

Time Frame: Preoperatively

It took the patient's age at the time of surgery

Study Sites (1)

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