Clinical trial NCT04286646: Correlation of Pupillary Diameter Changewith Age and Anterior Chamber Depth After Cataract Surgery
Official title: Correlation of Pupillary Diameter Change With Age and Anterior Chamber Depth After Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pupillary Disorders
Keywords: Cataract
Pupillary changes
Age
Anterior chamber depth
Lead sponsor: Clinica Oftalmologica TACIR
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 55
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Pupil diameter
timeFrame: Preoperatively and 3-months postoperatively
measure: Anterior Chamber Depht
timeFrame: Preoperatively
measure: Age
timeFrame: Preoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Clinica Oftalmológica TACIR
Study officials:
affiliation: Clinica Oftalmologica TACIR
name: Enrique Ordiñaga-Monreal, OD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.