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

NCT01164358 | Completed DMC

• 1 other identifier: 1002
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 4

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.

Conditions

Presbyopia

Keywords

Presbyopia; INTRACOR; patient satisfaction; long term

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Determination if there is any correlation between patient satisfaction and subjective/objective diagnostic data.

  36 months

Study Arms (2)

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)"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)"

You may qualify if:

• 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)"

You may not qualify if:

• 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

Sponsors & Collaborators

• Technolas Perfect Vision GmbH: lead

Study Sites (4)

University of Heidelberg, department Ophthamology

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

FreeVis LASIK Center Mannheim GmbH

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Augenklinik am Marienplatz AG & Co. KG

Munich, Bavaria, 80331, Germany

Location

ye-clinic for Refractive and Ophthalmo-Surgery, EJK Niederrhein

Duisburg, North Rhine-Westphalia, 47169, Germany

Location

Related Publications (1)

• Thomas BC, Fitting A, Khoramnia R, Rabsilber TM, Auffarth GU, Holzer MP. Long-term outcomes of intrastromal femtosecond laser presbyopia correction: 3-year results. Br J Ophthalmol. 2016 Nov;100(11):1536-1541. doi: 10.1136/bjophthalmol-2015-307672. Epub 2016 Feb 22.

  PMID: 26903524 DERIVED

MeSH Terms

Conditions

Presbyopia; Patient Satisfaction

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mike P. Holzer, Prof. Dr. med

  University of Heidelberg, department Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 16, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 21, 2013

Record last verified: 2013-10

Locations

DE (4)