Viewing Study NCT04831177



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Last Modification Date: 2024-10-26 @ 2:01 PM
Study NCT ID: NCT04831177
Status: COMPLETED
Last Update Posted: 2021-04-06
First Post: 2021-03-31

Brief Title: Thin-Flap Laser in Situ Keratomileusis Associated Dry Eye
Sponsor: Assiut University
Organization: Assiut University

Study Overview

Official Title: Thin-Flap Laser in Situ Keratomileusis Associated Dry Eye
Status: COMPLETED
Status Verified Date: 2021-04
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: Laser in situ keratomileusis LASIK eye surgery continues to be the most common refractive procedure used to correct different forms of ametropia Although the introduction of femtosecond technology has markedly reduced the incidence of intraoperative flap complications and allowed a better control on flap parameters dry eye remains one of the most challenging postoperative complications
Detailed Description: The pathophysiology of post LASIK dry eye is not clear however many mechanisms have been suggested including inflammation loss of conjunctival goblet cells during suction exacerbation of a preexisting dry eye abnormal interaction between the lid margins and the ocular surface Intact corneal sensation is crucial for proper tear production and distribution on the ocular surface as well as maintaining the normal dynamics of eyelid blinking Disruption of corneal nerves in LASIK decreases the release of neurotrophic factors necessary for the normal function of the corneal epithelium as well as the integrity of the lacrimal functional unit a condition referred to as LASIK induced neurotrophic epitheliopathy LINE that largely contributes to the development of post- LASIK dry eye

Many studies evaluated the incidence of post-refractive dry eye after LASIK compared to flapless laser vision correction LVC procedures such as PRK and small incision lenticule extraction SMILE The aim of this study is to assess and compare different dry eye parameters following LASIK with planned thin flaps created by femtosecond laser FS and mechanical microkeratome MK

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