Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-26 @ 10:15 PM
Study NCT ID:
NCT01025050
Status:
COMPLETED
Last Update Posted:
2011-06-09
First Post:
2009-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrastromal Presbyopia Correction by Means of a Femtosecond Laser
Sponsor:
Technolas Perfect Vision GmbH
Organization:
Study Overview
Official Title:
Intrastromal Presbyopia Correction by Means of a Femtosecond Laser
Status:
COMPLETED
Status Verified Date:
2011-06
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:
This clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. The hypothesis of the study is that by means of intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and effective way.
Detailed Description:
This clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. The incisions are applied by means of the FEMTEC femtosecond laser system with the INTRACOR software module using patterns consisting of 6 concentric rings and 3 different inner ring diameters. A similar pattern with 5 concentric rings and only one fixed inner diameter is currently under clinical investigation.
The hypothesis of the study is that by means of intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and effective way.
The intrastromal incisions are performed by the femtosecond laser FEMTEC, which is CE certified for various therapeutic indications. The incision eliminates both an epithelial and an endothelial opening of the cornea whereby the minimally invasive character of this form of treatment is guaranteed. A detailed pre-operative examination will ensure that every interested and willing patient fulfils the inclusion criteria of this study. Post-operative examinations, which should document the success of the treatment, are to be carried out after 24 hours, 1 week, 1 month, 3 months and 6 months.
The hypothesis of the study is that by means of intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and effective way.
The intrastromal incisions are performed by the femtosecond laser FEMTEC, which is CE certified for various therapeutic indications. The incision eliminates both an epithelial and an endothelial opening of the cornea whereby the minimally invasive character of this form of treatment is guaranteed. A detailed pre-operative examination will ensure that every interested and willing patient fulfils the inclusion criteria of this study. Post-operative examinations, which should document the success of the treatment, are to be carried out after 24 hours, 1 week, 1 month, 3 months and 6 months.
Study Oversight
Has Oversight DMC:
True
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?: