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

Completed

• Conditions: Pupillary Disorders

• Registration Number: NCT04286646
• Lead Sponsor: Clinica Oftalmologica TACIR

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.

Study Timeline

• Study Start: 2018-05-20
• Primary Completion: 2018-06-21
• Study Completion: 2019-12-30
• Status Verified: 2020-02
• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-27
• Last Update Submitted: 2020-02-28
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anterior Chamber Depht	Preoperatively	Anterior chamber depth was obtained with Pentacam® (Oculus Optikgeräte GmbH, Wetzlar, Germany).
Pupil diameter	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	Preoperatively	It took the patient's age at the time of surgery

Trial Locations

Locations (1)

Clinica Oftalmológica TACIR; 🇪🇸 Barcelona, Spain