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Active, Not Recruiting

NCT Number: NCT05628129

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ectopia Lentis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Abnormalities Eye Diseases Lens Diseases Lens Subluxation

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

smartphone application service and phone reminder

Other

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

Primary outcomes

  1. follow-up adherence at 3 months after surgery

    Time frame: 3 months

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

Secondary outcomes

  1. follow-up adherence at 1 week after surgery

    Time frame: 1 week

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

  2. follow-up adherence at 1 month after surgery

    Time frame: 1 month

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

  3. best corrected visual acuity

    Time frame: 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. replacement rates of glasses

    Time frame: 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

  5. amblyopia therapy rate

    Time frame: 3 months

    the rate of amblyopia therapy during 3 months after surgery

  6. referral rate due to systemic diseases

    Time frame: 3 months

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

  7. CEL knowledge score

    Time frame: 3 months

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

Other outcomes

  1. follow-up adherence at 6 months after surgery

    Time frame: 6 months

    the rates of attendance at 6 months (± 1 month) after surgery

  2. follow-up adherence at 1 year after surgery

    Time frame: 1 year

    the rates of attendance at 1 year (± 2 months) after surgery

  3. follow-up adherence at 2 years after surgery

    Time frame: 2 years

    the rates of attendance at 2 years (± 4 months) after surgery

  4. follow-up adherence at 3 years after surgery

    Time frame: 3 years

    the rates of attendance at 3 years (± 6 months) after surgery

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Nov 28, 2022
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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