Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04710082
Status:
COMPLETED
Last Update Posted:
2021-07-20
First Post:
2021-01-08
Brief Title:
Outcomes of a New Trans-epithelial Photorefractive Keratectomy Streamlight PRK Compared to Conventional PRK Procedures
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Outcomes of a New Trans-epithelial Photorefractive Keratectomy Streamlight PRK Compared to Conventional PRK Procedures
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:
Photorefractive keratectomy PRK involves mechanical or alcohol assisted debridement of the epithelium that leads to potential basement membrane BM injury with resultant more significant haze and pain compared to laser assisted epithelial removal known as 2 step trans-epithelial PRK PTK-PRK Our study is focusing on comparing the outcomes of the conventional 2 step trans-epithelial PTK-PRK to the new single step trans-epithelial PRK StreamLight PRK Alcon lab TX USA
Detailed Description:
Photorefractive keratectomy PRK is nowadays one of the commonest refractive procedures in laser vision correction LVC PRK differs from laser in situ keratomileusis LASIK in that its a flapless procedure involving the removal of corneal epithelium with different techniques including manual removal alcohol assisted removal or excimer laser assisted removal with phototherapeutic keratectomy PTK Mechanical or alcohol assisted debridement of the epithelium may lead to potential basement membrane BM injury with resultant more significant haze and pain compared to laser assisted epithelial removal known as 2 step trans-epithelial PRK PTK-PRK
Single step trans-epithelial PRK allows removing the epithelium and stroma in a single step with a single ablation profile
Previous studies paid particular attention for comparing the 2 step PTK-PRK procedure or the new single step PRK procedure to the conventional PRK procedures involving epithelial removal whether manual or alcohol assisted
The aim of this study is to focus on comparing the different outcomes of the new single step Trans-epithelial PRK StreamLight Technology versus the routine 2 step PTK-PRK in terms of postoperative vision epithelial healing pain scoring and haze evaluation
Single step trans-epithelial PRK allows removing the epithelium and stroma in a single step with a single ablation profile
Previous studies paid particular attention for comparing the 2 step PTK-PRK procedure or the new single step PRK procedure to the conventional PRK procedures involving epithelial removal whether manual or alcohol assisted
The aim of this study is to focus on comparing the different outcomes of the new single step Trans-epithelial PRK StreamLight Technology versus the routine 2 step PTK-PRK in terms of postoperative vision epithelial healing pain scoring and haze evaluation
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