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

NCT06429527 | Enrolling By Invitation DMC

• 1 other identifier: 2024KYPJ037
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Senile

Keywords

cataract; telemedicine; health economics; carbon emission; follow-up postoperatively

Outcome Measures

Primary Outcomes (1)

• The best corrected distant visual acuity (BCVA) of the operative eye

  Using the ETDRS chart to test the BCVA of the operative eye.

  1 month after cataract surgery

Secondary Outcomes (10)

• Incremental cost-effectiveness ratios (ICERs)

  1 month postoperatively

• Carbon emission

  1 week and 1 month postoperatively

• Uncorrected distant visual acuity (UDVA)of the operative eye

  1 month postoperatively

• Incidence and severity of postoperative complications

  Until 1 month postoperatively

• Incidence and severity of self-reported ocular discomfort

  Until 1 month postoperatively

Study Arms (2)

Remote follow-up

EXPERIMENTAL

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.

Behavioral: WHOeyes combined with a questionnaire.

Usual care

NO INTERVENTION

Participants routinely returned to the hospital for review 1 day, 1 week and 1 month post-cataract surgery

Interventions

WHOeyes combined with a questionnaire. BEHAVIORAL

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.

Remote follow-up

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead
• Eye & ENT Hospital of Fudan University: collaborator
• Shenzhen Eye Hospital: collaborator
• The Eye Hospital of Wenzhou Medical University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Beijing Tongren Hospital: collaborator
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 28, 2024
• Study Start: December 9, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CN (1)