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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164358
• Other study ID #: 1002
• Status: Completed
• Phase: N/A
• First received: July 15, 2010
• Last updated: October 18, 2013
• Start date: July 2010
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Technolas Perfect Vision GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Bavarian Health and Food Safety Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Presbyopia

Locations

Country	Name	City	State
Germany	ye-clinic for Refractive and Ophthalmo-Surgery, EJK Niederrhein	Duisburg	North Rhine-Westphalia
Germany	University of Heidelberg, department Ophthamology	Heidelberg	Baden-Württemberg
Germany	FreeVis LASIK Center Mannheim GmbH	Mannheim	Baden-Württemberg
Germany	Augenklinik am Marienplatz AG & Co. KG	Munic	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technolas Perfect Vision GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	long term satisfaction of patients post INTRACOR treatment based on a questionnaire	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.	36 months	No
Secondary	Determination if there is any correlation between patient satisfaction and subjective/objective diagnostic data.	Objective: Change in topographic map Subjective: uncorrected near visual acuity, uncorrected distance visual acuity	36 months	No