Evaluating App-Based Vision Testing (WHOeyes) Combined With the Questionnaire as a Substitute for… (NCT06429527) | Clinical Trial Compass
By InvitationNot Applicable
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
China334 participantsStarted 2024-12-09
Plain-language summary
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.
Who can participate
Age range50 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
The best corrected distant visual acuity (BCVA) of the operative eye
Timeframe: 1 month after cataract surgery
Trial details
NCT IDNCT06429527
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
. 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).