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

Sponsor

Technolas Perfect Vision GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT01164358

Collaborator

(none)

105

Enrollment

Locations

Duration (Months)

26.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Presbyopia

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.

Study Design

Study Type:

Observational

Actual Enrollment :

105 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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)"

Outcome Measures

Primary Outcome Measures

long term satisfaction of patients post INTRACOR treatment based on a questionnaire [36 months]
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. [36 months]
Objective: Change in topographic map Subjective: uncorrected near visual acuity, uncorrected distance visual acuity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Heidelberg, department Ophthamology	Heidelberg	Baden-Württemberg	Germany	69120
2	FreeVis LASIK Center Mannheim GmbH	Mannheim	Baden-Württemberg	Germany	68167
3	Augenklinik am Marienplatz AG & Co. KG	Munic	Bavaria	Germany	80331
4	ye-clinic for Refractive and Ophthalmo-Surgery, EJK Niederrhein	Duisburg	North Rhine-Westphalia	Germany	47169