Ignite Creation Date:
2024-05-06 @ 4:29 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05002036
Status:
COMPLETED
Last Update Posted:
2021-08-12
First Post:
2021-07-28
Brief Title:
Management of Dry Eye Disease After Cataract Surgery With Topical Hyaluronic Acid and Gingko Biloba
Sponsor:
University of Milan
Organization:
University of Milan
Study Overview
Official Title:
Evaluation of the Clinical Efficacy of Hyaluronic Acid and Gingko Biloba Eyedrops in the Management of Iatrogenic Dry Eye Disease Induced by Cataract Surgery
Status:
COMPLETED
Status Verified Date:
2021-07
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:
Cataract surgery is one of the main causes of Dry Eye Disease DED This paper aimed at evaluating the prevalence of iatrogenic DED on a population of patients without DED receiving cataract surgery and the impact of an eyedrop containing hyaluronic acid and gingko biloba HA-GB Trium free eyedrops Sooft srl Italy
In this phase-IV trial we enrolled 40 patients with no DED Patients were seen at baseline day 1 week 1 and week 4 At each visit patients received Ocular Surface Disease Index OSDI questionnaire Anterior segment ophthalmoscopy with grading of conjunctival hyperemia fluorescein tear break-up time TBUT grading of fluorescein corneal staining epithelial damage adherence and tolerability using a visual analogue scale were checked at week 1 and 4
At day 0 patients underwent cataract surgery 24 mm temporal incision and were randomized to standard postoperative care control group or standard postoperative care HA-GB given three times a day for 4 weeks HA-GB group
In this phase-IV trial we enrolled 40 patients with no DED Patients were seen at baseline day 1 week 1 and week 4 At each visit patients received Ocular Surface Disease Index OSDI questionnaire Anterior segment ophthalmoscopy with grading of conjunctival hyperemia fluorescein tear break-up time TBUT grading of fluorescein corneal staining epithelial damage adherence and tolerability using a visual analogue scale were checked at week 1 and 4
At day 0 patients underwent cataract surgery 24 mm temporal incision and were randomized to standard postoperative care control group or standard postoperative care HA-GB given three times a day for 4 weeks HA-GB group
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None