Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT06964867
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Multimedia Health Education to Reduce Anxiety in Patients With Vitreous Floaters
Sponsor:
Changzhou No.2 People's Hospital
Organization:
Study Overview
Official Title:
Effectiveness of Multimedia Health Education to Reduce Anxiety in Patients With Vitreous Floaters
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: