Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this open, prospective study is to address the effectiveness and precision of the VICTUS™ Femtosecond Laser Platform-assisted astigmatic keratotomy after femtolaser-assisted cataract surgery.
Corneal astigmatism after cataract surgery represents a considerable obstacle in the visual rehabilitation of patients. Up-to-date astigmatic keratotomy represents a standardized and effective procedure that allows decreasing of naturally occurring and surgically induced astigmatism. The shape and architecture of the Arcuate Incisions are pre-calculated based on a particular chosen nomogram. The different parameters of the Arcuate Incisions as radius, opening and position angle and cutting depth can be achieved precisely by the laser technology.
The laser-assisted Cataract surgery and the Arcuate Incisions are performed by means of a femtosecond laser (VICTUS™ FEMTOSECOND LASER PLATFORM®, Technolas Perfect Vision GmbH, Munich, Germany) which is in the presented study under investigation and is already CE-approved.
For this open, prospective data collection several selection criteria have been defined in order to obtain a data set of minimal 43 eyes and maximal 50 eyes. Depending on whether they will be treated unilateral or bilateral the number of subjects enrolled within this study sums up to 22-50 patients. The data is gathered in the Castrop-Rauxel Augenklinik and only from one experienced surgeon.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arcuate Incision | Experimental | Study arm will consist of patients who show cataract and corneal astigmatism. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arcuate incision | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| subjective cylinder | At the 3 month visit the subjective cylinder as measured with phoropter or trial frame is ≤ 0.75 D in 60% of the eyes. | 3 month postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| topographic corneal cylinder | At the 3 month visit the value of postoperative corneal astigmatism of the central 3 mm zone, measured with topography, is ≤ 1.0 D in 60% of the eyes | 3 month postoperative |
| abberrometric corneal astigmatism |
Not provided
Inclusion Criteria:
Clear corneal media
Patients must be at least 40 years of age
mono- or bilateral Cataract with uncorrected distance visual acuity (UCDVA)
Vectorial averaged astigmatism of keratometric and topographic astigmatism:
Patients must have read, understood the Patient Information and signed the informed consent form
Patients are willing and able to return for follow-up examinations
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Hoffmann, Dr. | Augen- & Laserklinik Castrop-Rauxel GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augen- & Laserklinik Castrop-Rauxel GmbH | Castrop-Rauxel | 44575 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34464547 | Derived | Wendelstein JA, Hoffmann PC, Schwarzenbacher L, Fischinger IR, Hirnschall N, Menapace R, Langenbucher A, Findl O, Bolz M. Lasting Effects: Seven Year Results of the Castrop Nomogram for Femtosecond Laser-Assisted Paired Corneal Arcuate Incisions. Curr Eye Res. 2022 Feb;47(2):225-232. doi: 10.1080/02713683.2021.1975761. Epub 2021 Sep 7. |
| Label | URL |
|---|---|
| Sponsor: Technolas Perfect Vision GmbH | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
At the 3 month visit the value of postoperative corneal astigmatism of the central 3 mm zone, measured with aberrometry, is ≤ 1.0 D in 60% of the eyes.
| 3 month postoperative |
| keratomic corneal astigmatism | At the 3 month visit the value of postoperative corneal astigmatism of the central 3 mm zone, measured with keratometry, is ≤ 1.0 D in 60% of the eyes | 3 month postoperative |
| correction index based on keratometric corneal astigmatism | At 3 month visit the value of the correction index based on preoperative and postoperative keratometric corneal astigmatism is 0.9+- 0,35 in 70% of the eyes. | 3 month postoperative |
| correction index based on | At 3 month visit the value of the correction index based on preoperative keratometric corneal astigmatism and postoperative subjective astigmatism is 0.9+- 0,35 in 70% of the eyes. | 3 month postoperative |
| Investigator's side | View source |