NCT06964867

Brief Summary

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

1.5 years

First QC Date

April 22, 2025

Last Update Submit

May 10, 2025

Conditions

Keywords

vitreous floatersanxietyhealth educationSTAIVFQ-25

Outcome Measures

Primary Outcomes (1)

  • State-Trait Anxiety Inventory scores

    This questionnaire comprise two 20-item subscales state anxity and trait anxiety: STAI-state evaluating transient emotional responses ("how you feel right now") and STAI-trait measuring stable anxiety predisposition ("how you generally feel"). The scores for each test ranged from 20 to 80 points, with higher scores indicating higher anxiety.Scoring followed Spielberger's manualized criteria. According to the Spielberger manual, STAI-state and STAI-trait are categorized as follows: mild anxiety ranges from 20 to 39, moderate anxiety from 40 to 59, and high anxiety from 60 to 80.

    before the intervention, 3months after the intervention

Secondary Outcomes (1)

  • Visual Function Quality 25 scores.

    before the intervention, 3months after the intervention

Study Arms (1)

the multimedia health education group

EXPERIMENTAL

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)

Other: Multimedia Health Education

Interventions

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)

the multimedia health education group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Second People's Hospital of Changzhou

Changzhou, Jiangsu, 213100, China

RECRUITING

MeSH Terms

Conditions

vitreous floatersAnxiety DisordersHealth Education

Condition Hierarchy (Ancestors)

Mental DisordersAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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; 2) Symptomatology; 3) Therapeutic modalities; 4) Follow-up necessity.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2025

First Posted

May 11, 2025

Study Start

December 1, 2023

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Locations