Trials / Completed
CompletedNCT01025050
Intrastromal Presbyopia Correction by Means of a Femtosecond Laser
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Technolas Perfect Vision GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Intrastromal Correction of Presbyopia | On all patients an intrastromal pattern consisting of concentric rings will be applied. |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2010-05-01
- Completion
- 2010-12-01
- First posted
- 2009-12-03
- Last updated
- 2011-06-09
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01025050. Inclusion in this directory is not an endorsement.