Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555224
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Role of Postoperative Lubrication in Cataract Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Role of Postoperative Lubrication in Preventing Dry Eye After Cataract Surgery
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cataract and dry eye are two conditions occurring frequently in the elderly Several reports suggested a deterioration of dry eye after cataract surgery causing a significant impact on patients postoperative satisfaction as well as quality of life Recently a novel index assessing the risk of developing dry eye after cataract surgery in a non-dry eye population was published the so called - Ocular Surface Frailty Index OSFI This score utilizes 10 items including clinical ocular findings medical history as well as environmental factors and grade the respective subject in low-risk- or high-risk group Using the cutoff of 03 the rate of postoperative dry eye was 96 in the low-risk group and 50 in the high-risk group p0001
Systane Hydration MDPF eye drops Alcon Research Ltd Fort Worth Texas USA a division of Novartis is an artificial tear substitute based on the dual-polymer formula containing HP-Guar and hyaluronic acid Previous studies found an increase in tear film stability and reduction of subjective complaints In an animal model corneas treated with Systane Hydration showed the fastest re-epithelialization compared to other HA products supporting the beneficial role of HA-containing artificial tears in corneal wound healing
The current study seeks to investigate if intensive lubrication using Systane Hydration MDPF in the postoperative phase of cataract surgery can reduce the rate of dry eye in the high-risk group The findings will have a great impact how to identify these patients to administer the adequate therapy which might hinder development of dry eye related to cataract surgery
The goal of this clinical trial is to learn if Systane Hydration MDPF eye drops Alcon Research Ltd Fort Worth Texas USA a division of Novartis works to treat prevent postoperative dry eye in adults undergoing cataract surgery The main questions it aims to answer are
- to investigate if intensive lubrication using Systane Hydration MDPF in the postoperative phase of cataract surgery can reduce the rate of dry eye in a high-risk group The findings will have a great impact how to identify these patients to administer the adequate therapy which might hinder development of dry eye related to cataract surgery
Participants will
Take Systane Hydration MDPF eye drops 4x daily for 3 months additional to or just the standard of care medication NSAID topical 2x daily for 4 weeks after surgery Visit the clinic after 7 days 1 month and 3 months after cataract surgery
Systane Hydration MDPF eye drops Alcon Research Ltd Fort Worth Texas USA a division of Novartis is an artificial tear substitute based on the dual-polymer formula containing HP-Guar and hyaluronic acid Previous studies found an increase in tear film stability and reduction of subjective complaints In an animal model corneas treated with Systane Hydration showed the fastest re-epithelialization compared to other HA products supporting the beneficial role of HA-containing artificial tears in corneal wound healing
The current study seeks to investigate if intensive lubrication using Systane Hydration MDPF in the postoperative phase of cataract surgery can reduce the rate of dry eye in the high-risk group The findings will have a great impact how to identify these patients to administer the adequate therapy which might hinder development of dry eye related to cataract surgery
The goal of this clinical trial is to learn if Systane Hydration MDPF eye drops Alcon Research Ltd Fort Worth Texas USA a division of Novartis works to treat prevent postoperative dry eye in adults undergoing cataract surgery The main questions it aims to answer are
- to investigate if intensive lubrication using Systane Hydration MDPF in the postoperative phase of cataract surgery can reduce the rate of dry eye in a high-risk group The findings will have a great impact how to identify these patients to administer the adequate therapy which might hinder development of dry eye related to cataract surgery
Participants will
Take Systane Hydration MDPF eye drops 4x daily for 3 months additional to or just the standard of care medication NSAID topical 2x daily for 4 weeks after surgery Visit the clinic after 7 days 1 month and 3 months after cataract surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None