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

2014-08-27 03:12:09 | BioPortfolio


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.


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 guranteed that every interested and agreeing patient fulfils the inclusion criteria of this study. The quantitative measuring values of the patient perception are assesed 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

Observational Model: Cohort, Time Perspective: Prospective




University of Heidelberg, department Ophthamology




Technolas Perfect Vision GmbH

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:12:09-0400

Clinical Trials [72 Associated Clinical Trials listed on BioPortfolio]

Presbyopia in Breast Cancer Survivors

Chemotherapy drugs, used in cancer treatments, may change the timing of a vision condition known as presbyopia. Presbyopia is the inability to focus the eye on close objects, by a process...

Phase 3 Efficacy Study of AGN-190584 in Participants With Presbyopia

A study to evaluate the efficacy, safety, and pharmacokinetics of AGN-190584 when administered bilaterally, once daily for 30 days in participants with presbyopia.

The Light Sword Lens for Presbyopia Compensation

Clinical assessment of a new optical element for presbyopia compensation - the Light Sword Lens.

A Phase 3 Efficacy Study of AGN-190584 in Participants With Presbyopia

This clinical study will evaluate AGN-190584 in an expanded participant population to establish efficacy, safety, and tolerability versus the vehicle-control when administered, over a 30-d...

Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00

The purpose of this study is to investigate visual outcomes and assess safety at 12 months (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting ...

PubMed Articles [12 Associated PubMed Articles listed on BioPortfolio]

Influence of presbyopia on smartphone usage among Chinese adults: a population study.

Presbyopia, an essentially-universal, age-related loss of the ability to focus un-aided on near objects, is the world's leading cause of visual impairment.

Visual Function after Implantation of a Presbyopia-Correcting Trifocal Intraocular Lens.

To evaluate distance, intermediate, and near visual performance in patients implanted with a trifocal aspheric presbyopia-correcting intraocular lens (IOL).

Presbyopia and Glaucoma: Two Diseases, One Pathophysiology? The Friedenwald Lecture.

Presbyopia and the aging eye: Existing refractive approaches and their potential impact on dry eye signs and symptoms.

Every part of the human body is subject to aging, including the eye. An increased prevalence of dry eye disease with age is widely acknowledged. Aging threatens ocular surface homeostasis, altering th...

Correction of presbyopia: old problems with old (and new) solutions.

We live in a three-dimensional world and the human eye can focus images from a wide range of distances by adjusting the power of the eye's lens (accommodation). Progressive senescent changes in the le...

Medical and Biotech [MESH] Definitions

The normal decreasing elasticity of the crystalline lens that leads to loss of accommodation.

More From BioPortfolio on "Long Term Observation of Patient Satisfaction Post INTRACOR Treatment Based on Patient Perception and Diagnostic Data"

Quick Search

Searches Linking to this Trial