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Ectopia LentisNCT05628129

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

A study testing smartphone application service and phone reminder in people with Ectopia Lentis, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Ectopia Lentis
What is being tested?
smartphone application service and phone reminder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteChina
Study dates
5 Dec 2022to Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Ectopia Lentis
Being tested
smartphone application service and phone reminder
Medical subject headings
Ectopia Lentis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • smartphone application service and phone reminderOther

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

Study groups in NCT05628129
Study groupRoleWhat they receive
reminder interventionExperimentalOn 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.
Receives: Other: smartphone application service and phone reminder
standard appointmentNo interventionPatients will be required to attend follow-up appointments at 1 week, 1 month, 3 months after surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. follow-up adherence at 3 months after surgery

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

    Measured: 3 months

Secondary outcomes (7)

  1. follow-up adherence at 1 week after surgery

    the rates of attendance at 1 week (± 2 days) after surgery

    Measured: 1 week

  2. follow-up adherence at 1 month after surgery

    the rates of attendance at 1 month (± 1 week) after surgery

    Measured: 1 month

  3. 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

    Measured: 3 months

  4. 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

    Measured: 3 months

  5. amblyopia therapy rate

    the rate of amblyopia therapy during 3 months after surgery

    Measured: 3 months

  6. referral rate due to systemic diseases

    referral rate due to abnormalities in skeletal system and cardiovascular system during 3 months after surgery

    Measured: 3 months

  7. CEL knowledge score

    change between baseline and endline scores on knowledge about CEL, including six choice questions concerning pathogenesis, symptoms and treatment of CEL

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2022
  2. Study start5 Dec 2022
  3. Primary completion20 Nov 2024
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05628129
Sponsor's protocol ID
IIT2022120
Status last verified
Feb 2025
First submitted
16 Nov 2022
Last updated
13 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22921386

  • 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.

    PubMed 30053472

  • 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.

    PubMed 32169922

  • 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.

    PubMed 30508618

  • 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.

    PubMed 33528369

  • 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.

    PubMed 27541442

  • 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.

    PubMed 40208617

Questions about this trial

What is this clinical trial studying?

A study testing smartphone application service and phone reminder in people with Ectopia Lentis, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

follow-up adherence at 3 months after surgery (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05628129, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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