Recruiting

Observational Study

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT04910282

Conditions

Covid19

Eye Diseases

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The ophthalmology clientele is vulnerable in the context of the coronavirus disease 2019 (COVID-19) pandemic because of their age and comorbidities. Specifically, elderly patients aged 65 and above with glaucoma, age-related macular degeneration, or diabetic retinopathy require regular follow-ups and commonly suffer from additional comorbidities. Further, because of the proximity between the patient and health care personnel during ophthalmological examinations, the risk of infection during visits is significant. The delicate balance between the risk of exposure to COVID-19 and visual loss in delaying cases is a psychological stressor to both patients and clinicians.

A cross-sectional study accumulating the data of 425 patients aged 65 and above with various eye diseases will be conducted. Participants will be presented with a set of online questionnaires designed to collect data on health-related quality of life (HRQOL), vision-related quality of life (VRQOL), depression symptoms, anxiety, sleep quality, community integration, and their experience with tele-consultations. This study can help quantify the collateral impact of the COVID-19 beyond the direct impact of the virus, to improve future quality of care guidelines on non-COVID-19 conditions, and to help plan patient prioritization once restrictions are eased.

Conditions

Covid19

Eye Diseases

Study ID

NCT04910282

Start date

Jan 1, 2023

Status verified date

Feb, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients diagnosed with an eye disease by an experienced ophthalmologist.
  • Patients with eye diseases age 65 and above.
  • Be able to provide valid informed consent to participate in the research study.
  • Being able to read and understand English.
  • Having no significant self-reported or a physician diagnosed mental health disorder.

Exclusion Criteria:

  • Inability to provide a valid informed consent.
  • Significant communication barriers or lack of English proficiency that prevents participants from completing the questionnaires.
  • Severe depression as confirmed by a CES-D ≥ 24.
  • Having a lifetime diagnosis of self-reported other serious mental disorders, including bipolar I or II disorder, primary psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder).
  • Self-reported substance abuse or dependence within the past 3 months.
  • Having an acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
  • Having irreversible vision loss that prevents one from completing the questionnaires.

Study Design

Enrollment

425 participants

Anticipated

Interventions and Outcome Measures

Arms

Eye Disease Patients

Patients with eye diseases age 65 and above will be included. Patients from the Ivey Eye Institute, St. Joseph's Health Care London, ON will be recruited in-person, based on inclusion and exclusion criteria.

Primary outcome measure

  • health-related quality of life (HRQoL) [ Time Frame: Immediately upon receiving the participant's consent to participate in the study ]

Central Contacts and Locations

Central contacts

Monali M Malvankar, PhD

5196858500monali.malvankar@sjhc.london.on.ca

Locations

St. Joseph's Hospital

Recruiting

London, Ontario, Canada, N6A4V2

Contacts

Monali Malvankar

5196858500

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Feb 5, 2024

Last verified

Feb, 2024

Keywords

  • Eye disease patients
  • Psychological stressors
  • COVID-19
  • Seniors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2024-02-05.