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Cataract SenileNCT06429527

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

A study testing WHOeyes combined with a questionnaire. in people with Cataract Senile, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Cataract Senile
What is being tested?
WHOeyes combined with a questionnaire.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
334 participants
Where
1 siteChina
Study dates
9 Dec 2024to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • 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).
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  • 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).
  • Ongoing systemic treatment for infectious diseases;
  • Presence of cachexia or bone marrow suppression.
  • Confirmed diagnosis of AIDS or positive test results for HIV antibodies.
  • 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.
  • 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).
  • Have pre-planned hospital visits during the study period, other than those required for postoperative follow-ups of the study eye;
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Zhongshan Ophthalmic Center, Sun Yat-Sen University

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

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.

Read more

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
Being tested
WHOeyes combined with a questionnaire.
Keywords
cataract, telemedicine, health economics, carbon emission, follow-up postoperatively
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WHOeyes combined with a questionnaire.Behavioural

    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.

Study groups in NCT06429527
Study groupRoleWhat they receive
Remote follow-upExperimentalOne 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.
Receives: Behavioral: WHOeyes combined with a questionnaire.
Usual careNo interventionParticipants routinely returned to the hospital for review 1 day, 1 week and 1 month post-cataract surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 1 month after cataract surgery

Secondary outcomes (10)

  1. Incremental cost-effectiveness ratios (ICERs)

    Mean difference in costs divided by mean difference in quality adjusted life years (QALYs).

    Measured: 1 month postoperatively

  2. Carbon emission

    Collect the carbon emission related activity data generated in the process of postoperative follow-up of patients and hospital through enquiry and questionnaire.

    Measured: 1 week and 1 month postoperatively

  3. Uncorrected distant visual acuity (UDVA)of the operative eye

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

    Measured: 1 month postoperatively

  4. Incidence and severity of postoperative complications

    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.

    Measured: Until 1 month postoperatively

  5. Incidence and severity of self-reported ocular discomfort

    Collected by self-reported outcomes and past medical records (if any) of subjects.

    Measured: Until 1 month postoperatively

  6. Number of unplanned visits

    Collected by self-reported outcomes and past medical records (if any) of subjects.

    Measured: Until 1 month after cataract surgery

  7. Patient reported outcome measures (PROMs): Catquest-9SF

    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.

    Measured: 1 month after cataract surgery

  8. Patient reported outcome measures (PROMs): NEI-VFQ-25

    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.

    Measured: 1 month after cataract surgery

  9. Patient reported outcome measures (PROMs): EQ-5D-5L

    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).

    Measured: 1 month after cataract surgery

  10. Users' satisfaction with the WHOeyes app

    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.

    Measured: 1 month after cataract surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2024
  2. Study start9 Dec 2024
  3. Primary completionMay 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
334 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06429527
Sponsor's protocol ID
2024KYPJ037
Status last verified
Apr 2026
First submitted
9 May 2024
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing WHOeyes combined with a questionnaire. in people with Cataract Senile, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The best corrected distant visual acuity (BCVA) of the operative eye (time frame: 1 month after cataract surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06429527.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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