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

Launched by ZHONGSHAN OPHTHALMIC CENTER, SUN YAT-SEN UNIVERSITY · May 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a vision testing app called WHOeyes, combined with a simple questionnaire, can effectively replace the standard in-clinic check-up that usually happens one week after cataract surgery. The researchers want to find out if this remote follow-up method can maintain patients' health and safety while also saving time and resources. They are looking for people aged 50 to 80 with uncomplicated senile cataracts who have a smartphone and can use the app after receiving some guidance.

Participants in the trial will visit the clinic one day and one month after their cataract surgery for routine follow-ups. However, instead of returning for the one-week check-up, they can use the app and complete the questionnaire from home. The trial aims to see if this new approach is just as effective as the traditional method while being more cost-effective and environmentally friendly. It's a great opportunity for eligible patients to help improve care for future cataract patients!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Senile cataract patients undergoing Phaco + IOL implantation under local anesthesia.
• • 2. Between 50 and 80 years of age, regardless of gender.
• • 3. 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.
• • 4. Able to understand and cooperate with the trial procedures, voluntarily participate in this clinical trial, and sign an informed consent form.
• Exclusion Criteria:
• 1. Had other serious eye diseases in addition to cataract, including:
• • 1. 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.
• • 2. Active ocular infection or inflammation in either eye.
• • 3. Episode of acute uveitis within the past 6 months in either eye.
• • 4. Intraocular pressure \>21mmHg or a history of glaucoma in the study eye.
• • 5. 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).
• • 6. Congenital abnormalities in the study eye (e.g., congenital cataracts, aniridia).
• • 7. Corrected visual acuity in the non-study eye \<0.1 (20/200).
• • 2. History of ocular trauma in the study eye.
• • 3. History of ocular surgery in the study eye, such as glaucoma surgery, vitrectomy, corneal refractive surgery, corneal transplantation.
• • 4. Scheduled ocular surgery in either eye during the study period, such as trabeculectomy, corneal transplantation.
• • 5. Occurrences of intraoperative and postoperative complications (e.g., elevated intraocular pressure, corneal edema) in the study eye within 1 day after cataract surgery.
• • 6. Corrected visual acuity of the study eye less than 0.5 (20/40) on postoperative day 1.
• 7. With severe chronic systemic diseases or are susceptible to infection, including:
• • 1. Poorly controlled diabetes (fasting blood glucose \>10 mmol/L).
• • 2. Poorly controlled hypertension (systolic blood pressure\>160mmHg or diastolic blood pressure\>100mmHg).
• • 3. Ongoing systemic treatment for infectious diseases;
• • 4. Presence of cachexia or bone marrow suppression.
• • 5. Confirmed diagnosis of AIDS or positive test results for HIV antibodies.
• • 6. 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.
• • 8. 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).
• • 9. Have pre-planned hospital visits during the study period, other than those required for postoperative follow-ups of the study eye;
• • 10. 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.