## Protocol Section
### Identification Module
**NCT ID:** NCT06429527

**Brief Title:** Vision Test App and Questionnaire for 1-Week Post-Cataract Surgery Follow-Up: 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

#### Organization Study ID Info
**ID:** 2024KYPJ037
#### Organization
**Class:** OTHER
**Full Name:** Zhongshan Ophthalmic Center, Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2024-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** West China Hospital

**Class:** OTHER

**Name:** People's Hospital of Guangxi

**Class:** OTHER

**Name:** Beijing Tongren Hospital

**Class:** OTHER

**Name:** Eye & ENT Hospital of Fudan University

**Class:** OTHER

**Name:** Shanxi Eye Hospital

**Class:** OTHER

**Name:** Shenzhen Eye Hospital

**Class:** OTHER

**Name:** The Eye Hospital of Wenzhou Medical University

**Class:** OTHER

**Name:** The First Affiliated Hospital of Zhengzhou University

#### Lead Sponsor

**Class:** OTHER

**Name:** Zhongshan Ophthalmic Center, Sun Yat-sen University

#### Responsible Party

**Investigator Affiliation:** Zhongshan Ophthalmic Center, Sun Yat-sen University

**Investigator Full Name:** Lixia Luo

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Cataract Senile

**Keywords:**

- cataract

- telemedicine

- health economics

- carbon emission

- follow-up postoperatively

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 334

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: WHOeyes combined with a questionnaire.

**Label:** Remote follow-up

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Usual care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Remote follow-up

**Description:** 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.

**Name:** WHOeyes combined with a questionnaire.

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Using the ETDRS chart to test the BCVA of the operative eye.

**Measure:** The best corrected distant visual acuity (BCVA) of the operative eye

**Time Frame:** 1 month after cataract surgery

#### Secondary Outcomes

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

**Measure:** Incremental cost-effectiveness ratios (ICERs)

**Time Frame:** 1 month postoperatively

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

**Measure:** Carbon emission

**Time Frame:** 1 week and 1 month postoperatively

**Description:** Using the ETDRS chart to test the UDVA of the operative eye.

**Measure:** Uncorrected distant visual acuity (UDVA)of the operative eye

**Time Frame:** 1 month postoperatively

**Description:** 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.

**Measure:** Incidence and severity of postoperative complications

**Time Frame:** Until 1 month postoperatively

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

**Measure:** Incidence and severity of self-reported ocular discomfort

**Time Frame:** Until 1 month postoperatively

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

**Measure:** Number of unplanned visits

**Time Frame:** Until 1 month after cataract surgery

**Description:** 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.

**Measure:** Patient reported outcome measures (PROMs): Catquest-9SF

**Time Frame:** 1 month after cataract surgery

**Description:** 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.

**Measure:** Patient reported outcome measures (PROMs): NEI-VFQ-25

**Time Frame:** 1 month after cataract surgery

**Description:** 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).

**Measure:** Patient reported outcome measures (PROMs): EQ-5D-5L

**Time Frame:** 1 month after cataract surgery

**Description:** 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.

**Measure:** Users' satisfaction with the WHOeyes app

**Time Frame:** 1 month after cataract surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Senile cataract patients undergoing Phaco + IOL implantation for the first time under local anesthesia.
2. Aged between 50 and 80 years old (inclusive), regardless of gender.
3. Possession of a smartphone and capable of understanding and correctly installing and using WHOeyes for visual acuity examination after physician's guidance, .
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. Complicated with other serious eye diseases except cataract.

   1. History of chronic or recurrent diseases during screening (e.g., keratitis or corneal malnutrition, iritis, scleritis, uveitis, iridocyclitis, excluding refractive errors, dry eye, and chronic conjunctivitis).
   2. Presence of ocular infection or active inflammation in either eye during screening.
   3. History of acute uveitis within the past 6 months during screening.
   4. Intraocular pressure \>21mmHg or a history of glaucoma in the study eye during screening.
   5. Presence of unstable active lesions or other ocular diseases judged by the investigator to potentially affect the evaluation of this trial or subject safety, such as moderate to severe diabetic retinopathy, wet age-related macular degeneration, retinal detachment, etc.
   6. Congenital abnormalities in the study eye (e.g., congenital cataracts, aniridia).
   7. Best corrected visual acuity in the non-operative eye \<0.1.
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. Planned ocular surgery in either eye during the trial period, such as trabeculectomy, corneal transplantation.
5. Occurrence of complications (e.g., elevated intraocular pressure, corneal edema) within 1 day after cataract surgery.
6. Implantation of a functional intraocular lens (Toric or multifocal intraocular lens).
7. Best corrected visual acuity of the operative eye less than 0.5 within 1 day after surgery.
8. People with severe chronic systemic diseases or who are susceptible to infection.

   1. Poorly controlled diabetes (fasting blood sugar \>10 mmol/L) during screening.
   2. Poorly controlled hypertension (systolic blood pressure ≥140mmHg, diastolic blood pressure ≥90mmHg) during screening.
   3. Require systemic treatment for infectious diseases during screening;
   4. With cachexia or bone marrow suppression.
   5. History of acquired immunodeficiency syndrome or positive human immunodeficiency virus antibodies during screening.
   6. Presence of other 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.
9. Participation in other clinical trials within the past month (excluding those who only participated in clinical trial screening without using trial drugs or devices).
10. Pregnant or lactating women.
11. Patients deemed unsuitable for participation in this trial for other reasons by the investigator.

**Maximum Age:** 80 Years

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007905

- Term: Lens Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5638

- Name: Cataract

- Relevance: HIGH

- As Found: Cataract

- ID: M10917

- Name: Lens Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002386

- Term: Cataract

### Misc Info Module

- Version Holder: 2024-05-31
