Evaluating App-Based Vision Testing (WHOeyes) Combined With the Questionnaire as a Substitute for One-Week Postoperative In-Clinic Follow-Up in Age-Related Cataract Patients: A Multi-center Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if an app-based vision testing (WHOeyes) combined with a questionnaire can recognize those who have to go back to the hospital, and thus replace the in-clinic 1-week review after an uncomplicated cataract surgery in people with senile cataract. It will also learn about the cost-effectiveness and environmental benefits of such remote follow-up pattern. Besides, the safety and user's satisfaction will also be evaluated. The main questions it aims to answer are: For people with uncomplicated senile cataract, does 1-week clinical follow-up replaced with remote follow-up (using a vision test app and a questionnaire) not adversely affect patients' prognosis? Can this alternative approach bring greater cost-effectiveness and environmental friendliness compared to the traditional follow-up method? Researchers will compare one-week remote follow-up to a routine clinical follow-up to see if one-week remote follow-up is feasible. Participants will: Visit the clinic to finish routine follow-up 1 day and 1 month after cataract surgery. Using app (WHOeyes) and a questionnaire at home or visit the clinic 1 week after cataract surgery.

Вмешательства

• Поведенческое WHOeyes combined with a questionnaire.
  The WHOeyes app (a self-administered visual acuity testing app) plus a questionnaire (to ask the patients to go to the hospital if they ever experience ocular discomfort including eye redness, discharge, etc.) will be used for 1-week follow-up after cataract surgery, and only those with significant vision loss based on WHOeye test or with ocular discomfort are advised to return to the hospital for follow-up.

Первичные конечные точки

• The best corrected distant visual acuity (BCVA) of the operative eye [Срок оценки: 1 month after cataract surgery]

Вторичные конечные точки (10)

• Incremental cost-effectiveness ratios (ICERs) [Срок оценки: 1 month postoperatively]
• Carbon emission [Срок оценки: 1 week and 1 month postoperatively]
• Uncorrected distant visual acuity (UDVA)of the operative eye [Срок оценки: 1 month postoperatively]
• Incidence and severity of postoperative complications [Срок оценки: Until 1 month postoperatively]
• Incidence and severity of self-reported ocular discomfort [Срок оценки: Until 1 month postoperatively]
• Number of unplanned visits [Срок оценки: Until 1 month after cataract surgery]
• Patient reported outcome measures (PROMs): Catquest-9SF [Срок оценки: 1 month after cataract surgery]
• Patient reported outcome measures (PROMs): NEI-VFQ-25 [Срок оценки: 1 month after cataract surgery]
• Patient reported outcome measures (PROMs): EQ-5D-5L [Срок оценки: 1 month after cataract surgery]
• Users' satisfaction with the WHOeyes app [Срок оценки: 1 month after cataract surgery]

Критерии участия

Критерии включения

• Senile cataract patients undergoing Phaco + IOL implantation under local anesthesia.
• Between 50 and 80 years of age, regardless of gender.
• The subject or their family members own a smartphone, understand and can correctly install and use the WHOeyes app for vision testing under the guidance of a physician.
• Able to understand and cooperate with the trial procedures, voluntarily participate in this clinical trial, and sign an informed consent form.

Критерии исключения

• Had other serious eye diseases in addition to cataract, including:

• Chronic or recurrent eye diseases of the study eye, such as keratitis or corneal malnutrition, iritis, scleritis, uveitis, iridocyclitis. (Note: refractive errors, dry eye, chronic conjunctivitis, and mild pterygium are not exclusionary.
• Active ocular infection or inflammation in either eye.
• Episode of acute uveitis within the past 6 months in either eye.
• Intraocular pressure >21mmHg or a history of glaucoma in the study eye.
• Presence of unstable active lesions or other ocular diseases of the study eye that, in the investigator's judgment, could potentially interfere with the study evaluation or compromise subject safety (e.g., moderate to severe diabetic retinopathy, wet age-related macular degeneration, retinal detachment).
• Congenital abnormalities in the study eye (e.g., congenital cataracts, aniridia).
• Corrected visual acuity in the non-study eye <0.1 (20/200).
• History of ocular trauma in the study eye.
• History of ocular surgery in the study eye, such as glaucoma surgery, vitrectomy, corneal refractive surgery, corneal transplantation.
• Scheduled ocular surgery in either eye during the study period, such as trabeculectomy, corneal transplantation.
• Occurrences of intraoperative and postoperative complications (e.g., elevated intraocular pressure, corneal edema) in the study eye within 1 day after cataract surgery.
• Corrected visual acuity of the study eye less than 0.5 (20/40) on postoperative day 1.
• With severe chronic systemic diseases or are susceptible to infection, including:

• Poorly controlled diabetes (fasting blood glucose >10 mmol/L).
• Poorly controlled hypertension (systolic blood pressure>160mmHg or diastolic blood pressure>100mmHg).
• Ongoing systemic treatment for infectious diseases;
• Presence of cachexia or bone marrow suppression.
• Confirmed diagnosis of AIDS or positive test results for HIV antibodies.
• Presence of severe cardiovascular, pulmonary, hepatic, renal, endocrine, immune, dermatological, musculoskeletal, neurological, or psychiatric diseases, hearing impairment, or mobility impairment, as deemed unsuitable for participation in this trial by the investigator.
• Participation in other clinical trials within the last 30 days (excluding those who only participated in screening process without receiving any investigational drugs or devices).
• Have pre-planned hospital visits during the study period, other than those required for postoperative follow-ups of the study eye;
• Any other condition or circumstance that, in the investigator's judgment, makes the patient unsuitable for participation in this trial.

Note: The study eye refers to the eye that underwent cataract surgery and is included in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• Zhongshan Ophthalmic Center, Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT06429527 · 2024KYPJ037

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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