Effect of Mobile Communication on Congenital Ectopia Lentis Follow-up Adherence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of WeChat Application Combined Phone Reminder on Follow-up Adherence Improvement in Congenital Ectopia Lentis Patients : A Randomized Controlled Trial

Conditions
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Ectopia Lentis

Intervention / Treatment
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* Other: smartphone application service and phone reminder


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: reminder intervention<br>On the basis of standard appointment, parents in intervention group will receive phone reminders at 4 days and 1 day before their scheduled appointments, and relevant scientific and educational knowledge will be relayed to them from the smartphone application at 1 week before appointments. | Other: smartphone application service and phone reminder<br>* smartphone application service and phone reminder for appointments of parents of congenital ectopia lentis patients<br>|
| No Intervention: standard appointment<br>Patients will be required to attend follow-up appointments at 1 week, 1 month, 3 months after surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| follow-up adherence at 3 months after surgery | the rates of attendance at 3 months (± 3 weeks) after surgery | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| follow-up adherence at 1 week after surgery | the rates of attendance at 1 week (± 2 days) after surgery | 1 week | 
| follow-up adherence at 1 month after surgery | the rates of attendance at 1 month (± 1 week) after surgery | 1 month | 
| best corrected visual acuity | measurement of best corrected visual acuity was carried out using a logarithm of the Minimum Angle of Resolution (logMAR) chart at the baseline and endline visits | 3 months | 
| incidence of complications | Including: postoperative high IOP, postoperative macular edema, knot/suture-related complications and so on | 3 months | 
| replacement rates of glasses | If the difference between the current refraction and the currently worn eyeglass prescription was greater than 2 diopters sphere and/or greater than 1 diopter cylinder, a new prescription was given | 3 months | 
| amblyopia therapy rate | the rate of amblyopia therapy during 3 months after surgery | 3 months | 
| secondary surgery rate | the rate of secondary surgery during 3 months after surgery | 3 months | 
| referral rate due to systemic diseases | referral rate due to abnormalities in skeletal system and cardiovascular system during 3 months after surgery | 3 months | 
| CEL knowledge score | change between baseline and endline scores on knowledge about CEL, including six choice questions concerning pathogenesis, symptoms and treatment of CEL | 3 months |