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Completed

NCT Number: NCT04286646

Correlation of Pupillary Diameter Changewith 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

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Oftalmológica TACIR

Barcelona, 08022, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Pupil diameter

    Time frame: 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).

  2. Anterior Chamber Depht

    Time frame: Preoperatively

    Anterior chamber depth was obtained with Pentacam® (Oculus Optikgeräte GmbH, Wetzlar, Germany).

  3. Age

    Time frame: Preoperatively

    It took the patient's age at the time of surgery

Sponsors and collaborators

Lead sponsor

Clinica Oftalmologica TACIR

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 27, 2020
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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