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

Ectopia Lentis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05628129
• Other study ID #: IIT2022120
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2022
• Est. completion date: April 2025

Study information

• Verified date: February 2023
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Danying Zheng, M.D
• Phone: 020-87330478
• Email: zhengdyy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ectopia Lentis

Intervention

Other:
• smartphone application service and phone reminder
smartphone application service and phone reminder for appointments of parents of congenital ectopia lentis patients

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (6)

Bi J, Yang W, Hao P, Zhao Y, Wei D, Sun Y, Lin Y, Sun M, Chen X, Luo X, Li S, Zhang W, Wang X. WeChat as a Platform for Baduanjin Intervention in Patients With Stable Chronic Obstructive Pulmonary Disease in China: Retrospective Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Feb 2;9(2):e23548. doi: 10.2196/23548. — View Citation

Chen T, Zhu W, Tang B, Jin L, Fu H, Chen Y, Wang C, Zhang G, Wang J, Ye T, Xiao D, Vignarajan J, Xiao B, Kanagasingam Y, Congdon N. A Mobile Phone Informational Reminder to Improve Eye Care Adherence Among Diabetic Patients in Rural China: A Randomized Controlled Trial. Am J Ophthalmol. 2018 Oct;194:54-62. doi: 10.1016/j.ajo.2018.07.006. Epub 2018 Jul 24. — View Citation

Lin H, Chen W, Luo L, Congdon N, Zhang X, Zhong X, Liu Z, Chen W, Wu C, Zheng D, Deng D, Ye S, Lin Z, Zou X, Liu Y. Effectiveness of a short message reminder in increasing compliance with pediatric cataract treatment: a randomized trial. Ophthalmology. 2012 Dec;119(12):2463-70. doi: 10.1016/j.ophtha.2012.06.046. Epub 2012 Aug 24. — View Citation

Lin J, Gong N, Cao Q, Zhou Y, Cai Y, Jin G, Young CA, Yang J, Wang Y, Zheng D. What hinders congenital ectopia lentis patients' follow-up visits? A qualitative study. BMJ Open. 2020 Mar 12;10(3):e030434. doi: 10.1136/bmjopen-2019-030434. — View Citation

Tan J, Christie A, Montalvo SK, Wallace C, Yan Y, Folkerts M, Yingling A, Sher D, Choy H, Jiang S, Westover KD. Automated Text Message Reminders Improve Radiation Therapy Compliance. Int J Radiat Oncol Biol Phys. 2019 Apr 1;103(5):1045-1052. doi: 10.1016/j.ijrobp.2018.11.050. Epub 2018 Nov 30. — View Citation

Yang K, Jin L, Li L, Zeng S, Wei R, Li G, Man P, Congdon N. Interventions to Promote Follow-up After Trabeculectomy Surgery in Rural Southern China: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1135-1141. doi: 10.1001/jamaophthalmol.2016.2819. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	follow-up adherence at 3 months after surgery	the rates of attendance at 3 months (± 3 weeks) after surgery	3 months
Secondary	follow-up adherence at 1 week after surgery	the rates of attendance at 1 week (± 2 days) after surgery	1 week
Secondary	follow-up adherence at 1 month after surgery	the rates of attendance at 1 month (± 1 week) after surgery	1 month
Secondary	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
Secondary	incidence of complications	Including: postoperative high IOP, postoperative macular edema, knot/suture-related complications and so on	3 months
Secondary	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
Secondary	amblyopia therapy rate	the rate of amblyopia therapy during 3 months after surgery	3 months
Secondary	secondary surgery rate	the rate of secondary surgery during 3 months after surgery	3 months
Secondary	referral rate due to systemic diseases	referral rate due to abnormalities in skeletal system and cardiovascular system during 3 months after surgery	3 months
Secondary	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