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

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

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

Study Overview

• Status: Completed
• Conditions: Pupillary Disorders

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 Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08022
    • Clinica Oftalmológica TACIR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pupil diameter before/after cataract; The investigators measure the pupil diameter before and after (3 months) cataract. Mesopic and photopic conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Clinica Oftalmologica TACIR
• Investigators: Principal Investigator: Enrique Ordiñaga-Monreal, OD, Clinica Oftalmológica TACIR

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2018
• Primary Completion (Actual): June 21, 2018
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 28, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Cataract; Age; Pupillary changes; Anterior chamber depth
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Lens Diseases; Cataract; Capsule Opacification; Pupil Disorders
• Other Study ID Numbers: EC022018; 47/2018 (Other Identifier: CEIm Grupo Hospitalario Quirónsalud-Catalunya)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No