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| Name | Class |
|---|---|
| Eye & ENT Hospital of Fudan University | OTHER |
| Shenzhen Eye Hospital | OTHER |
| The Eye Hospital of Wenzhou Medical University | OTHER |
| The First Affiliated Hospital of Zhengzhou University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Usual care | No Intervention | Participants routinely returned to the hospital for review 1 day, 1 week and 1 month post-cataract surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental cost-effectiveness ratios (ICERs) | Mean difference in costs divided by mean difference in quality adjusted life years (QALYs). | 1 month postoperatively |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Had other serious eye diseases in addition to cataract, including:
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-Sen University | Guangzhou | Guangdong | 510000 | China |
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| OTHER |
| Beijing Tongren Hospital | OTHER |
| People's Hospital of Guangxi Zhuang Autonomous Region | OTHER |
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
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| 1 week and 1 month postoperatively |
| Uncorrected distant visual acuity (UDVA)of the operative eye | Using the ETDRS chart to test the UDVA of the operative eye. | 1 month postoperatively |
| 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 |
| 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 |
| Number of unplanned visits | Collected by self-reported outcomes and past medical records (if any) of subjects. | Until 1 month after cataract surgery |
| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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