Clinical trial NCT06429527: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cataract Senile
Keywords: cataract
telemedicine
health economics
carbon emission
follow-up postoperatively
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Eye & ENT Hospital of Fudan University
name: Shenzhen Eye Hospital
name: The Eye Hospital of Wenzhou Medical University
name: The First Affiliated Hospital of Zhengzhou University
name: Beijing Tongren Hospital
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: Second Affiliated Hospital of Xi'an Jiaotong University
First posted: 2024-05-28
Enrollment: 334
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: The best corrected distant visual acuity (BCVA) of the operative eye
timeFrame: 1 month after cataract surgery
Secondary outcomes:
measure: Incremental cost-effectiveness ratios (ICERs)
timeFrame: 1 month postoperatively
measure: Carbon emission
timeFrame: 1 week and 1 month postoperatively
measure: Uncorrected distant visual acuity (UDVA)of the operative eye
timeFrame: 1 month postoperatively
measure: Incidence and severity of postoperative complications
timeFrame: Until 1 month postoperatively
measure: Incidence and severity of self-reported ocular discomfort
timeFrame: Until 1 month postoperatively
measure: Number of unplanned visits
timeFrame: Until 1 month after cataract surgery
measure: Patient reported outcome measures (PROMs): Catquest-9SF
timeFrame: 1 month after cataract surgery
measure: Patient reported outcome measures (PROMs): NEI-VFQ-25
timeFrame: 1 month after cataract surgery
measure: Patient reported outcome measures (PROMs): EQ-5D-5L
timeFrame: 1 month after cataract surgery
measure: Users' satisfaction with the WHOeyes app
timeFrame: 1 month after cataract surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-Sen University
state: Guangdong
Study officials:
References: