NCT05628129

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Dec 2022Nov 2027

First Submitted

Initial submission to the registry

November 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 28, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

December 5, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Expected
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

November 16, 2022

Last Update Submit

February 10, 2025

Conditions

Ectopia Lentis

Outcome Measures

Primary Outcomes (1)

  • follow-up adherence at 3 months after surgery

    the rates of attendance at 3 months (± 3 weeks) after surgery

    3 months

Secondary Outcomes (7)

  • follow-up adherence at 1 week after surgery

    1 week

  • follow-up adherence at 1 month after surgery

    1 month

  • best corrected visual acuity

    3 months

  • replacement rates of glasses

    3 months

  • amblyopia therapy rate

    3 months

  • +2 more secondary outcomes

Other Outcomes (4)

  • follow-up adherence at 6 months after surgery

    6 months

  • follow-up adherence at 1 year after surgery

    1 year

  • follow-up adherence at 2 years after surgery

    2 years

  • +1 more other outcomes

Study Arms (2)

reminder intervention

EXPERIMENTAL

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

standard appointment

NO INTERVENTION

Patients will be required to attend follow-up appointments at 1 week, 1 month, 3 months after surgery.

Interventions

smartphone application service and phone reminderOTHER

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

reminder intervention

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \. 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.

You may not qualify if:

  • \. With Other ophthalmic diseases such as glaucoma, uveitis and corneal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (7)

  • 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.

    PMID: 22921386BACKGROUND

  • 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.

    PMID: 30053472BACKGROUND

  • 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.

    PMID: 32169922BACKGROUND

  • 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.

    PMID: 30508618BACKGROUND

  • 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.

    PMID: 33528369BACKGROUND

  • 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.

    PMID: 27541442BACKGROUND

  • Ma Y, Zhang X, Jin L, Liu S, Liang X, Ye Q, Liu X, Congdon N, Zheng D, Jin G. Social Media Interventions and Postoperative Follow-Up in Congenital Ectopia Lentis: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 May 1;143(5):438-445. doi: 10.1001/jamaophthalmol.2025.0526.

    PMID: 40208617DERIVED

MeSH Terms

Conditions

Ectopia Lentis

Condition Hierarchy (Ancestors)

Eye AbnormalitiesEye DiseasesLens SubluxationLens DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Danying Zheng, M.D

    Clinical Research Center of Zhongshan Ophthalmic Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2022

First Posted

November 28, 2022

Study Start

December 5, 2022

Primary Completion

November 20, 2024

Study Completion (Estimated)

November 1, 2027

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)