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

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05628129
Collaborator
(none)
104
1
2
27.9
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: smartphone application service and phone reminder
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Effect of WeChat Application Combined Phone Reminder on Follow-up Adherence Improvement in Congenital Ectopia Lentis Patients : A Randomized Controlled Trial
Anticipated Study Start Date :
Dec 5, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: reminder intervention

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

No Intervention: standard appointment

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

Outcome Measures

Primary Outcome Measures

  1. follow-up adherence at 3 months after surgery [3 months]

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

Secondary Outcome Measures

  1. follow-up adherence at 1 week after surgery [1 week]

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

  2. follow-up adherence at 1 month after surgery [1 month]

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

  3. best corrected visual acuity [3 months]

    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

  4. incidence of complications [3 months]

    Including: postoperative high IOP, postoperative macular edema, knot/suture-related complications and so on

  5. replacement rates of glasses [3 months]

    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

  6. amblyopia therapy rate [3 months]

    the rate of amblyopia therapy during 3 months after surgery

  7. secondary surgery rate [3 months]

    the rate of secondary surgery during 3 months after surgery

  8. referral rate due to systemic diseases [3 months]

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

  9. CEL knowledge score [3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Identified with congenital lens dislocation after surgery and age ≤ 18 years old;
  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

  • Principal Investigator: Danying Zheng, M.D, Clinical Research Center of Zhongshan Ophthalmic Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05628129
Other Study ID Numbers:
  • IIT2022120
First Posted:
Nov 28, 2022
Last Update Posted:
Nov 28, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 28, 2022