Clinical trial NCT05628129: Effect of Mobile Communication on Congenital Ectopia Lentis Follow-up Adherence
Official title: Effect of WeChat Application Combined Phone Reminder on Follow-up Adherence Improvement in Congenital Ectopia Lentis Patients : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ectopia Lentis
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 110
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Regular follow-up is essential to successful management of congenital ectopia lentis, but it is often ignored by parents in China.

With rapid economic development, there are increasing numbers of mobile phone users that allow for communication applications to be used in medical care.

The investigators aimed to assess the potential of the smartphone application assisted medical service to increase patient compliance in attendance of follow-up after congenital ectopia lentis treatment.

Detailed description: Congenital ectopia lentis is a rare ophthalmic disease that seriously harms the physical and mental health of patients. Surgery is the only definite treatment at present. However, severe visual impairment is common in congenital ectopia lentis patients in China, and delayed presentation to hospital and late surgical treatment are found to be the major reasons.

In China, the messaging application WeChat has become the most popular communication tool. As most congenital ectopia lentis patients' parents are younger people, they are more likely to use technology, such as WeChat, in their daily lives. In addition, it allows ophthalmologists to utilize this communication application to relay health related information and reminders to patients. This makes it feasible to apply this smartphone application in improving attendance of follow-up visits.

In this trial, the investigators aimed to assess the potential of the smartphone application assisted medical service to increase patient compliance in attendance of follow-up after congenital ectopia lentis treatment.

Eligibility criteria: Inclusion Criteria:

* 1. Identified with congenital lens dislocation after surgery and age ≤ 18 years old; 2. Parents were able to access a mobile phone and communicate via the smartphone application (WeChat); 3. Agree to participate in this study and sign the informed consent.

Exclusion Criteria:

* 1. With Other ophthalmic diseases such as glaucoma, uveitis and corneal disease.

Primary outcomes:
measure: follow-up adherence at 3 months after surgery
timeFrame: 3 months
Secondary outcomes:
measure: follow-up adherence at 1 week after surgery
timeFrame: 1 week
measure: follow-up adherence at 1 month after surgery
timeFrame: 1 month
measure: best corrected visual acuity
timeFrame: 3 months
measure: replacement rates of glasses
timeFrame: 3 months
measure: amblyopia therapy rate
timeFrame: 3 months
measure: referral rate due to systemic diseases
timeFrame: 3 months
measure: CEL knowledge score
timeFrame: 3 months
Other outcomes:
measure: follow-up adherence at 6 months after surgery
timeFrame: 6 months
measure: follow-up adherence at 1 year after surgery
timeFrame: 1 year
measure: follow-up adherence at 2 years after surgery
timeFrame: 2 years
measure: follow-up adherence at 3 years after surgery
timeFrame: 3 years
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Clinical Research Center of Zhongshan Ophthalmic Center
name: Danying Zheng, M.D
role: PRINCIPAL_INVESTIGATOR
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