Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-29 @ 10:47 AM
Study NCT ID:
NCT06914232
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-06
First Post:
2025-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Warm Compress Therapy in Enhancing Tear Film Quality and Reducing Postoperative DES
Sponsor:
Superior University
Organization:
Study Overview
Official Title:
Efficacy of Warm Compress Therapy in Enhancing Tear Film Quality and Reducing Postoperative Dry Eye Syndrome After Cataract Surgery: A Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
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:
Dry eye disease (DED) is a multifactorial condition often exacerbated by cataract surgery, leading to discomfort and visual disturbances. Meibomian gland dysfunction (MGD), a key cause of DED, contributes to tear film instability, which can be managed with warm compress therapy.
Detailed Description:
This study aims to evaluate the effectiveness of perioperative warm compress therapy (TPT) in improving tear film stability and reducing dry eye symptoms following cataract surgery. This randomized controlled trial (RCT) will involve 54 patients with estimated attrition rate 60 participants aged 50-70 with moderate to severe dry eye symptoms and tear film instability, as indicated by high Ocular Surface Disease Index (OSDI) scores. Participants will be randomly assigned to either an intervention group, receiving warm compress therapy before and after surgery, or a control group receiving standard dry eye treatments for 6 weeks.
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?:
None
Is an FDA AA801 Violation?: