Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510000, China
NCT Number: NCT06429527
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.
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: The study eye refers to the eye that underwent cataract surgery and is included in this study.
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.
Time frame: 1 month after cataract surgery
Using the ETDRS chart to test the BCVA of the operative eye.
Time frame: 1 month postoperatively
Mean difference in costs divided by mean difference in quality adjusted life years (QALYs).
Time frame: 1 week and 1 month postoperatively
Collect the carbon emission related activity data generated in the process of postoperative follow-up of patients and hospital through enquiry and questionnaire.
Time frame: 1 month postoperatively
Using the ETDRS chart to test the UDVA of the operative eye.
Time frame: Until 1 month postoperatively
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.
Time frame: Until 1 month postoperatively
Collected by self-reported outcomes and past medical records (if any) of subjects.
Time frame: Until 1 month after cataract surgery
Collected by self-reported outcomes and past medical records (if any) of subjects.
Time frame: 1 month after cataract surgery
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.
Time frame: 1 month after cataract surgery
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.
Time frame: 1 month after cataract surgery
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).
Time frame: 1 month after cataract surgery
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.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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