Vision Test App and Questionnaire for 1-Week Post-Cataract Surgery Follow-Up: A Multi-Center Randomized Controlled Trial

Cataract Senile Clinical 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06429527
• Other study ID #: 2024KYPJ037
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: November 2024

Study information

• Verified date: May 2024
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 334
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Senile

Intervention

Behavioral:
• WHOeyes combined with a questionnaire.
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.

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University	Beijing Tongren Hospital, Eye & ENT Hospital of Fudan University, People's Hospital of Guangxi, Shanxi Eye Hospital, Shenzhen Eye Hospital, The Eye Hospital of Wenzhou Medical University, The First Affiliated Hospital of Zhengzhou University, West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incremental cost-effectiveness ratios (ICERs)	Mean difference in costs divided by mean difference in quality adjusted life years (QALYs).	1 month postoperatively
Secondary	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.	1 week and 1 month postoperatively
Secondary	Uncorrected distant visual acuity (UDVA)of the operative eye	Using the ETDRS chart to test the UDVA of the operative eye.	1 month postoperatively
Secondary	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.	Until 1 month postoperatively
Secondary	Incidence and severity of self-reported ocular discomfort	Collected by self-reported outcomes and past medical records (if any) of subjects.	Until 1 month postoperatively
Secondary	Number of unplanned visits	Collected by self-reported outcomes and past medical records (if any) of subjects.	Until 1 month after cataract surgery
Secondary	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.	1 month after cataract surgery
Secondary	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.	1 month after cataract surgery
Secondary	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).	1 month after cataract surgery
Secondary	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.	1 month after cataract surgery