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Recruiting NCT06964867

Effectiveness of Multimedia Health Education to Reduce Anxiety in Patients With Vitreous Floaters

No phase Interventional Vitreous Floaters Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multimedia Health Education.
Who it may be relevant to
Registry conditions: Vitreous Floaters, Anxiety. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The patients with vitreous floaters were randomly divided into to groups after excluding the possibility of coexisting ocular pathologies potentially confounding visual symptoms or vitreoretinal anatomy. The control group performed conventional oral education. The experimental group conducted multimedia health education activities on the basis of conventional oral education. Their VRQoL (Visual Function Questionnaire-25, VFQ-25) and anxiety status (State-Trait Anxiety Inventory, STAI) were evaluated before education and at the final follow-up. The demographic and clinical characteristics (gender, age, eduaction, duration of vitreous floaters, comorbidities and so on) were collected.

Detailed description

Patients inclusion criteria: 1)Patients with VF visited the Department of Ophthalmology, the third affiliated hospital of Nanjing Medical University between December 2023 and April 2025; 2) Endogenously derived subjective floaters confirmed by comprehensive ophthalmic examination including slit-lamp biomicroscopy, dilated fundoscopy, optical coherence tomography (OCT) and so on; 3) Willing to participate in the multimedia health education program and complete validated questionnaires, with written informed consent obtained.

exclusion criteria:

1)Secondary VF requiring surgical intervention (e.g., vitreous hemorrhage, retinal breaks, or uveitis); 2) Coexisting ocular pathologies potentially confounding visual symptoms or vitreoretinal anatomy (e.g., diabetic retinopathy, retinal vascular occlusion, epiretinal membrane, or vitreomacular traction syndrome); 3) History of vitreoretinal surgery (PPV or laser procedures); 4) Refusal or inability to complete study protocols.

Intervention:

Multimedia health education was designed as an intervention. This intervention was administered by a single vitreoretinal specialist with over a decade of clinical experience. This standardized protocol comprised a 30-minute didactic session utilizing power point presentations (PPT), systematically covering: 1) Etiopathogenesis: molecular mechanisms of vitreous syneresis and collagen aggregation; 2) Symptomatology: characteristic visual phenomena and differential diagnosis; 3) Therapeutic modalities: evidence hierarchy from observation to vitrectomy (including Nd:YAG laser efficacy controversies); 4) Follow-up necessity: red flag symptoms warranting urgent re-evaluation (sudden floaters with photopsia). Multimedia presentation was made through pictures, texts, sounds, and videos. The simple and easy-to-understand language were used to make population easy to accept.

All participants underwent comprehensive ophthalmic evaluations comprising best-corrected visual acuity (BCVA), slit-lamp biomicroscopy with anterior segment analysis, dilated fundus examination incorporating scanning laser ophthalmoscopy (SLO) and spectral-domain optical coherence tomography (SD-OCT) to exclude vitreoretinal interface pathologies such as epiretinal membranes, macular holes and so on. Demographic and clinical baseline characteristics were systematically recorded, including gender, age, educational attainment, sympotom duration, presence or absence of photopsia, time of using electronic products daily, comorbidities, shape of floaters, diopter, psychometric and visual-related quality of life (VRQoL) assessments using National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and State-Trait Anxiety Inventory (STAI). To minimize intervention selection bias, a pragmatic temporal allocation protocol was implemented: Patients attending the clinic during odd-numbered calendar weeks were prospectively allocated to the multimedia health education group whereas those presenting during even-numbered weeks comprised the routine verbal group.

At the 3-month follow-up, both groups completed validated the VFQ-25 and STAI-state questionnaires via phone or wechat.

Interventions

  • Other Multimedia Health Education
    Multimedia health education was designed as an intervention. This intervention was administered by a single vitreoretinal specialist with over a decade of clinical experience. This standardized protocol comprised a 30-minute didactic session utilizing power point presentations (PPT), systematically covering: 1) Etiopathogenesis: Molecular mechanisms of vitreous syneresis and collagen aggregation; 2) Symptomatology: Characteristic visual phenomena and differential diagnosis; 3) Therapeutic modali

Primary outcome measures

  • State-Trait Anxiety Inventory scores [Time frame: before the intervention, 3months after the intervention]
Secondary outcome measures (1)
  • Visual Function Quality 25 scores. [Time frame: before the intervention, 3months after the intervention]

Eligibility criteria

Inclusion criteria

  • Clinical diagnosis of vitreous floaters;
  • Be able to complete questionnaires.

Exclusion criteria

  • Secondary VF requiring surgical intervention;
  • Coexisting ocular pathologies potentially confounding vitreoretinal anatomy;
  • History of vitreoretinal surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

China · 1 center
  • the Second People's Hospital of Changzhou — Changzhou

Identifiers

NCT: NCT06964867 · 213001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗