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

Sponsor

Clinica Oftalmologica TACIR (Other)

Overall Status

Completed

CT.gov ID

NCT04286646

Collaborator

(none)

Enrollment

Location

19.4

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

55 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 20, 2018

Actual Primary Completion Date :

Jun 21, 2018

Actual Study Completion Date :

Dec 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Pupil diameter before/after cataract The investigators measure the pupil diameter before and after (3 months) cataract. Mesopic and photopic conditions

Outcome Measures

Primary Outcome Measures

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).
Anterior Chamber Depht [Preoperatively]
Anterior chamber depth was obtained with Pentacam® (Oculus Optikgeräte GmbH, Wetzlar, Germany).
Age [Preoperatively]
It took the patient's age at the time of surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.