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

Pupillary Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04286646
• Other study ID #: EC022018
• Secondary ID: 47/2018
• Status: Completed
• Start date: May 20, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2020
• Source: Clinica Oftalmologica TACIR
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 30, 2019
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Pupillary Disorders

Locations

Country	Name	City	State
Spain	Clinica Oftalmológica TACIR	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Oftalmologica TACIR

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Anterior Chamber Depht	Anterior chamber depth was obtained with Pentacam® (Oculus Optikgeräte GmbH, Wetzlar, Germany).	Preoperatively
Primary	Age	It took the patient's age at the time of surgery	Preoperatively