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A Study to Address Precision and Refractive Predictability of Femtosecond Laser-assisted Astigmatic Keratotomy Following the Cataract Surgery

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
arcuate incision
Sponsored by
Technolas Perfect Vision GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism focused on measuring Femto-second Laser, arcuate incision, corneal astigmatism, astigmatic keratotomy, Cataract

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clear corneal media
  • Patients must be at least 40 years of age

  • mono- or bilateral Cataract with uncorrected distance visual acuity (UCDVA)

    • 0.63 or glare sensitivity

  • Vectorial averaged astigmatism of keratometric and topographic astigmatism:

    • 1.0 D and ≤ 2.0 D
  • 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:

  • The maximum K- value may not exceed 60D, the minimal value may not be smaller than 37D
  • Pachymetry does not include examination results at an radius of 4.25 mm
  • Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
  • Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
  • Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
  • Manifest Glaucoma
  • Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
  • Known sensitivity to planned concomitant medications
  • Patients regularly taking medicines that could influence the result of the treatment respectively the vision
  • Patients with disorders of the ocular muscle, such as nystagmus or strabismus
  • Patients with keratoconus, keratectasia or other irregular cornea changes
  • Patients with connective tissue weakness
  • Patients who are blind on one eye
  • Subjects who are immune compromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis, collagenosis and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study.
  • Abnormal examination results from slit lamp, fundus examination or IOL Master, age related changes are acceptable
  • Patients with eye diseases which decreases the visual acuity such as macular degeneration, macular edema, proliferative diabetic Retinopathy
  • Abnormal examination results from Topography, age related changes are acceptable
  • Patients who are pregnant or nursing
  • Patients with concentration disorders, epilepsy and other complicating diseases
  • Patients who are participating in another clinical study 30 days before

Sites / Locations

  • Augen- & Laserklinik Castrop-Rauxel GmbH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arcuate Incision

Arm Description

Study arm will consist of patients who show cataract and corneal astigmatism.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
abberrometric corneal astigmatism
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.
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
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.
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.

Full Information

First Posted
December 14, 2012
Last Updated
May 21, 2014
Sponsor
Technolas Perfect Vision GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01752218
Brief Title
A Study to Address Precision and Refractive Predictability of Femtosecond Laser-assisted Astigmatic Keratotomy Following the Cataract Surgery
Official Title
A Single Centre Study to Address Precision and Refractive Predictability of Femtosecond Laser-assisted Astigmatic Keratotomy Following the Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technolas Perfect Vision GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
Keywords
Femto-second Laser, arcuate incision, corneal astigmatism, astigmatic keratotomy, Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arcuate Incision
Arm Type
Experimental
Arm Description
Study arm will consist of patients who show cataract and corneal astigmatism.
Intervention Type
Device
Intervention Name(s)
arcuate incision
Primary Outcome Measure Information:
Title
subjective cylinder
Description
At the 3 month visit the subjective cylinder as measured with phoropter or trial frame is ≤ 0.75 D in 60% of the eyes.
Time Frame
3 month postoperative
Secondary Outcome Measure Information:
Title
topographic corneal cylinder
Description
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
Time Frame
3 month postoperative
Title
abberrometric corneal astigmatism
Description
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.
Time Frame
3 month postoperative
Title
keratomic corneal astigmatism
Description
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
Time Frame
3 month postoperative
Title
correction index based on keratometric corneal astigmatism
Description
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.
Time Frame
3 month postoperative
Title
correction index based on
Description
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.
Time Frame
3 month postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clear corneal media Patients must be at least 40 years of age mono- or bilateral Cataract with uncorrected distance visual acuity (UCDVA) 0.63 or glare sensitivity Vectorial averaged astigmatism of keratometric and topographic astigmatism: 1.0 D and ≤ 2.0 D 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: The maximum K- value may not exceed 60D, the minimal value may not be smaller than 37D Pachymetry does not include examination results at an radius of 4.25 mm Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc. Manifest Glaucoma Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye Known sensitivity to planned concomitant medications Patients regularly taking medicines that could influence the result of the treatment respectively the vision Patients with disorders of the ocular muscle, such as nystagmus or strabismus Patients with keratoconus, keratectasia or other irregular cornea changes Patients with connective tissue weakness Patients who are blind on one eye Subjects who are immune compromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis, collagenosis and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study. Abnormal examination results from slit lamp, fundus examination or IOL Master, age related changes are acceptable Patients with eye diseases which decreases the visual acuity such as macular degeneration, macular edema, proliferative diabetic Retinopathy Abnormal examination results from Topography, age related changes are acceptable Patients who are pregnant or nursing Patients with concentration disorders, epilepsy and other complicating diseases Patients who are participating in another clinical study 30 days before
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Hoffmann, Dr.
Organizational Affiliation
Augen- & Laserklinik Castrop-Rauxel GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augen- & Laserklinik Castrop-Rauxel GmbH
City
Castrop-Rauxel
ZIP/Postal Code
44575
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34464547
Citation
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.
Results Reference
derived
Links:
URL
http://www.technolaspv.com/
Description
Sponsor: Technolas Perfect Vision GmbH
URL
http://www.augenklinik-castrop-rauxel.de/
Description
Investigator's side

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A Study to Address Precision and Refractive Predictability of Femtosecond Laser-assisted Astigmatic Keratotomy Following the Cataract Surgery

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