NCT04910282|UnknownDMC
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Sponsor study identifier
observational
425
1 country
1
Study Start
January 1, 2023
Actual (reported)Primary Completion
December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 31, 2021
Actual (reported)June 2, 2021
Actual (reported)January 1, 2023
Actual (reported)December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
health-related quality of life (HRQoL)
HRQoL is an essential measure of quality of life related to health; it helps physician identify hidden morbidity in clinical care as well as improves patient-physician communications. HRQoL will be measured using time trade-off questionnaire. It is measured in a scale of 0 to 1, with higher scores indicating a better outcome. This means that 0 indicates poor HRQoL and 1 indicates perfect health.
Immediately upon receiving the participant's consent to participate in the study
Visual Function Score
Immediately upon receiving the participant's consent to participate in the study
Depression
Immediately upon receiving the participant's consent to participate in the study
Anxiety
Immediately upon receiving the participant's consent to participate in the study
Sleep Quality
Immediately upon receiving the participant's consent to participate in the study
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.
Patients from the Ivey Eye Institute, St. Joseph's Health Care London, ON will be recruited in-person based on inclusion and exclusion criteria.
St. Joseph's Hospital
London, Ontario, N6A4V2, Canada
Globe DR, Varma R, Torres M, Wu J, Klein R, Azen SP; Los Angeles Latino Eye Study Group. Self-reported comorbidities and visual function in a population-based study: the Los Angeles Latino Eye Study. Arch Ophthalmol. 2005 Jun;123(6):815-21. doi: 10.1001/archopht.123.6.815.
Sabel BA, Wang J, Cardenas-Morales L, Faiq M, Heim C. Mental stress as consequence and cause of vision loss: the dawn of psychosomatic ophthalmology for preventive and personalized medicine. EPMA J. 2018 May 9;9(2):133-160. doi: 10.1007/s13167-018-0136-8. eCollection 2018 Jun.
Monali Malvankar
Western University, Canada
First Submitted
May 31, 2021
First Posted
June 2, 2021
Study Start
January 1, 2023
Actual (reported)Primary Completion
December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
COVID Infection in Pediatric Surgical Patient
Contact the study team to confirm eligibility.
Salari N, Hosseinian-Far A, Jalali R, Vaisi-Raygani A, Rasoulpoor S, Mohammadi M, Rasoulpoor S, Khaledi-Paveh B. Prevalence of stress, anxiety, depression among the general population during the COVID-19 pandemic: a systematic review and meta-analysis. Global Health. 2020 Jul 6;16(1):57. doi: 10.1186/s12992-020-00589-w.
Lam DSC, Wong RLM, Lai KHW, Ko CN, Leung HY, Lee VYW, Lau JYN, Huang SS. COVID-19: Special Precautions in Ophthalmic Practice and FAQs on Personal Protection and Mask Selection. Asia Pac J Ophthalmol (Phila). 2020 Mar-Apr;9(2):67-77. doi: 10.1097/APO.0000000000000280.
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
Aylward, Bruce (WHO); Liang, W. (PRC). Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19). 2020; vol. 2019 16-24.
Quillen DA. Common causes of vision loss in elderly patients. Am Fam Physician. 1999 Jul;60(1):99-108.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 5, 2024
Record last verified: 2024-02
The code key with identifying data (ID #, phone #, date of birth, date of first assessment/consent, date of exit from the study, and any adverse events) will be stored in a password-protected and encrypted spreadsheet on the hospital network shared drive. We do not anticipate the questionnaire data collection to take longer than 12 months, and do not anticipate data analysis to take longer than 12 months thereafter (total of 12 months' time), with an absolute maximum of 15 years in post study completion prior to destruction of the data.
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Source: ClinicalTrials.gov.
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