Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04616144
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-07
First Post:
2020-10-26
Brief Title:
Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism
Sponsor:
Eye Hospital Pristina Kosovo
Organization:
Eye Hospital Pristina Kosovo
Study Overview
Official Title:
Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
The refractive combination of high hyperopia with high astigmatism is difficult to treat surgically In addition there are not many suitable options to offer such patients presenting with this condition The method used at the EYE Hospital Pristina using fresh lenticule implantation by ReLex-SMILE is safe and effective method Fresh Corneal Implantation is a safe treatment for hyperopia with high astigmatism comparing with refractive IOL implantation loss of accommodation endophthalmitis Its primary objective is to increase visual acuity accommodation process patient satisfaction which makes patient to enjoy a happier life We believe this study will be the future of refractive surgery for treating high hyperopia
Detailed Description:
This study is to investigate the effect of fresh corneal lenticule implantation as allogenic implant that will be taken from myopic patients to implant in hyperopic patients with high astigmatism using VisuMax Femtosecond laser - Smile module surgery with primary objective to assess increase visual acuity far intermediate near vision and secondary objective to stabilize decrease high astigmatism by reducing K-values
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