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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- The best corrected distant visual acuity (BCVA) of the operative eye
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
- •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
- •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.
研究组 & 干预措施
Remote follow-up
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.
干预措施: WHOeyes combined with a questionnaire. (Behavioral)
Usual care
Participants routinely returned to the hospital for review 1 day, 1 week and 1 month post-cataract surgery
结局指标
主要结局
The best corrected distant visual acuity (BCVA) of the operative eye
时间窗: 1 month after cataract surgery
Using the ETDRS chart to test the BCVA of the operative eye.
次要结局
- Users' satisfaction with the WHOeyes app(1 month after cataract surgery)
- Incidence and severity of postoperative complications(Until 1 month postoperatively)
- Incidence and severity of self-reported ocular discomfort(Until 1 month postoperatively)
- Patient reported outcome measures (PROMs): Catquest-9SF(1 month after cataract surgery)
- Patient reported outcome measures (PROMs): EQ-5D-5L(1 month after cataract surgery)
- Uncorrected distant visual acuity (UDVA)of the operative eye(1 month postoperatively)
- Incremental cost-effectiveness ratios (ICERs)(1 month postoperatively)
- Carbon emission(1 week and 1 month postoperatively)
- Number of unplanned visits(Until 1 month after cataract surgery)
- Patient reported outcome measures (PROMs): NEI-VFQ-25(1 month after cataract surgery)
研究者
Lixia Luo
Professor
Zhongshan Ophthalmic Center, Sun Yat-sen University