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

Not Applicable

• Conditions: Cataract Senile
• Interventions: Behavioral: WHOeyes combined with a questionnaire.

• Registration Number: NCT06429527
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-20
• Study First Posted: 2024-05-28
• Status Verified: 2024-11
• Study Start: 2024-12-09
• Last Update Submitted: 2025-01-25
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-10
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 334

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote follow-up	WHOeyes combined with a questionnaire.	One week postoperatively, the participants use the WHOeyes app to test their uncorrected visual acuity and fill in a self-made discomfort identification questionnaire. Visit the clinics for review 1 day and 1 month post-cataract surgery.

Primary Outcome Measures

Name	Time	Method
The best corrected distant visual acuity (BCVA) of the operative eye	1 month after cataract surgery	Using the ETDRS chart to test the BCVA of the operative eye.

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of postoperative complications	Until 1 month postoperatively	The proportion of postoperative complications of cataract in the two groups 1 week after surgery was calculated, and the postoperative complications were diagnosed by professional doctors.
Incidence and severity of self-reported ocular discomfort	Until 1 month postoperatively	Collected by self-reported outcomes and past medical records (if any) of subjects.
Patient reported outcome measures (PROMs): Catquest-9SF	1 month after cataract surgery	Vision-specific quality of life is measured by the Chinese version of 9-item short-form of Catquest questionnaire (Catquest-9SF). There are five text response options for the answers scaled from "Yes, very great difficulties" to "No, no difficulties" including answer "Cannot decide". The minimum score is 9 and maximum score is 36, and lower scores mean a better outcome.
Patient reported outcome measures (PROMs): EQ-5D-5L	1 month after cataract surgery	Health-related quality of life as measured by the Chinese version of five-level EuroQol five-dimensional questionnaire (EQ-5D-5L). The overall answer for the five dimensions can be combined into a five-digit number that describes the patient's health state. The raw scores are also converted to an EQ-5D index value (Chinese value set) ranging from -0.391 (worst perceived health state) to 1 (best perceived health state).
Users' satisfaction with the WHOeyes app	1 month after cataract surgery	Assessed by a self-made questionnaire, the answer of it can converted into a 5-point scale. The minimum value is 1 and the maximum value is 5. The higher the scores are, the greater the satisfaction the users have.
Uncorrected distant visual acuity (UDVA)of the operative eye	1 month postoperatively	Using the ETDRS chart to test the UDVA of the operative eye.
Incremental cost-effectiveness ratios (ICERs)	1 month postoperatively	Mean difference in costs divided by mean difference in quality adjusted life years (QALYs).
Carbon emission	1 week and 1 month postoperatively	Collect the carbon emission related activity data generated in the process of postoperative follow-up of patients and hospital through enquiry and questionnaire.
Number of unplanned visits	Until 1 month after cataract surgery	Collected by self-reported outcomes and past medical records (if any) of subjects.
Patient reported outcome measures (PROMs): NEI-VFQ-25	1 month after cataract surgery	Vision-specific quality of life as measured by the Chinese version of National Eye Institute Visual Function Questionnaire (NEI-VFQ-25). The minimum score is 0 and maximum score is 100, and higher scores mean a better outcome.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China