Long Term Observation of Patient Satisfaction Post INTRACOR Treatment Based on Patient Perception and Diagnostic Data

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier:
NCT01164358
First received: July 15, 2010
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

This study is a prospective, open, not randomized, unilateral multicenter eye study consisting of two study arms to observe the long term satisfaction of patients after an INTRACOR treatment. The satisfaction is determined with the help of the patient perception and the subjective / objective diagnostic data.

The hypothesis of the study is that patients after an INTRACOR treatment are satisfied in the long term.


Condition
Presbyopia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Observation of Patient Satisfaction Post INTRACOR Treatment Based on Patient Perception and Diagnostic Data

Further study details as provided by Technolas Perfect Vision GmbH:

Primary Outcome Measures:
  • long term satisfaction of patients post INTRACOR treatment based on a questionnaire [ Time Frame: 36 months ] [ Designated as safety issue: No ]

    Satisfaction is assesed by three questions:

    Do you fell comfortable with the treatment result? Would you do the traetment again? Would you recommend the treatment to a relativ or a friend?

    If two out of these three questions are answered with "yes" then it can be assumed that the patient is satisfied.



Secondary Outcome Measures:
  • Determination if there is any correlation between patient satisfaction and subjective/objective diagnostic data. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Objective: Change in topographic map Subjective: uncorrected near visual acuity, uncorrected distance visual acuity


Enrollment: 105
Study Start Date: July 2010
Study Completion Date: October 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
study arm I
patients who have been enrolled in the previous study "Intrastromal Correction of Ametropia by Femtosecond Laser (study ISCAF), study arm 1, Presbyopia sub-group: treatment pattern 5-Rings"
study arm II
patients who have been enrolled in the previous study "Intrastromal Presbyopia Correction by Means of Femtosecond Laser (study # 0905)"

Detailed Description:

The study is divided into two study arms. The first study arm includes patients of the preceding study "Intrastromal Correction of Ametropia by Femtosecond Laser (study ISCAF), study arm 1, Presbyopia sub-group: treatment pattern 5-Rings" and the second study arm includes patients of the previous "Intrastromal Presbyopia Correction by Means of Femtosecond Laser (study # 0905)".

The hypothesis of the study is that patients after a INTRACOR treatment are satisfied in the long term.

By detailed patient information and a clarification conversation it is guaranteed that every interested and agreeing patient fulfils the inclusion criteria of this study. The quantitative measuring values of the patient perception are assessed by a questionnaire. For measuring the subjective / objective diagnostic data only certificated diagnostic devices are used. No invasive intervention in the eye will be made to change the visual acuity.

Within the scope of the study between 98 and 135 patients should be examined. 49 to 63 patient are intended for the first study arm and 49 to 72 for the second study arm.

The follow-up examinations are carried out at 12 months and/or 24 months as well as for 36 months after the INTRACOR treatment. The study end points are determined for all follow-up examinations. The aim criteria should be reached for the final examination, which is after 36 months, at the latest.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Just patients who have been already enrolled in the previous study "Intrastromal Correction of Ametropia by Femtosecond Laser (study ISCAF), study arm 1, Presbyopia sub-group: treatment pattern 5-Rings" or "Intrastromal Presbyopia Correction by Means of Femtosecond Laser (study # 0905)"

Criteria

Inclusion Criteria:

  • Age: at least 18 years old
  • Patients must have read, understood and signed the Patient Information
  • Patients are willing and able to return for follow-up examinations
  • Patient has been already enrolled in the previous study "Intrastromal Correction of Ametropia by Femtosecond Laser (study ISCAF), study arm 1, Presbyopia sub-group: treatment pattern 5-Rings" or "Intrastromal Presbyopia Correction by Means of Femtosecond Laser (study # 0905)"

Exclusion Criteria:

  • Continual wearing of contact lenses before the follow-up examination . Patients must refrain from wearing contact lenses for at least 14 days prior to these dates
  • Patients who are pregnant or are lactating
  • Patients who are participating in another ophthalmological clinical study except "Intrastromal Presbyopia Correction by Means of Femtosecond Laser (study # 0905)"
  • severe sick people who cannot give any information on their visual acuity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164358

Locations
Germany
University of Heidelberg, department Ophthamology
Heidelberg, Baden-Württemberg, Germany, 69120
FreeVis LASIK Center Mannheim GmbH
Mannheim, Baden-Württemberg, Germany, 68167
Augenklinik am Marienplatz AG & Co. KG
Munic, Bavaria, Germany, 80331
ye-clinic for Refractive and Ophthalmo-Surgery, EJK Niederrhein
Duisburg, North Rhine-Westphalia, Germany, 47169
Sponsors and Collaborators
Technolas Perfect Vision GmbH
Investigators
Principal Investigator: Mike P. Holzer, Prof. Dr. med University of Heidelberg, department Ophthalmology
  More Information

No publications provided

Responsible Party: Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier: NCT01164358     History of Changes
Other Study ID Numbers: 1002
Study First Received: July 15, 2010
Last Updated: October 18, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Bavarian Health and Food Safety Authority

Keywords provided by Technolas Perfect Vision GmbH:
Presbyopia
INTRACOR
patient satisfaction
long term

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014