Trial document




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  DRKS00000459

Trial Description

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Title

Prospective clinical study to evaluate efficacy of ICOLENS TM, a bifocal corneal implant to treat presbyopia

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Presbyopia is caused by an age-related process and affects the near visual acuity. The ICOLENS TM is a treatment method, which is designed to correct presbyopia. Part of this clinical study is the impact and compatibility be demonstrated. This evidence is supplied to a statistically significant improvement in near visual acuity is detected. The study objectives are achieved if the subject of symptoms after treatment with the ICOLENS TM and may not be required for activities in near distances everyday on reading glasses. The ICOLENS TM is introduced in a minimally invasive procedure in the cornea of one eye (the non-dominant eye). The bifocal character of the lens causes good vision in both distances; near and far.

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Brief Summary in Scientific Language

The aim of the trial is the provision of evidence of efficacy and tolerability Icolens TM system for the correction of presbyopia. This evidence is supplied to the study participants may, after insertion of the Icolens TM quent near activities on reading glasses without the binocular distance aquity would noticeably impaired. In addition to a subjective statement about the quality of the study participants with the Icolens TM system are obtained.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00000459
  •   2010/06/24
  •   [---]*
  •   yes
  •   Approved
  •   95/10, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

  •   U1111-1115-4699 
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Health Condition or Problem studied

  •   H52.4 -  Presbyopia
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Interventions/Observational Groups

  •   Contribution of the Icolens TM into the cornea.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
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Primary Outcome

Significant improvement after the introduction of the near visual acuity of the Icolens TM measured by the "Freiburg Visual Acuity Test" at 33 cm and an illumination of 315 lux compared to the near visual acuity before operation.It will be measured preoperative and 1 week, 1 month, 3 months, 6 months, 12 months after surgery.

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Secondary Outcome

Significant improvement of the (binocular) measured reading ability compared with the situation before the intervention with the "Radner Reading Test" at 315 lux ambient lighting. Measured preoperative, 1 month, 6 months, 12 months after surgery.

Impact of the introduction of the binocular Icolens TM visual acuity for the distance significantly lower than 1.5 logMAR steps with the "Freiburg Visual Acuity test measured" at 600cm and a room illumination of 315 lux. Measured preoperative, 1 week, 1 month, 3 months, 6 months, 12 months after surgery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2010/06/29
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   45   Years
  •   65   Years
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Additional Inclusion Criteria

Aged 45-65 years; no acute or chronic systemic disease (connective tissue disease as a consequence of immune deficiencies, uncontrolled diabetes, cancer); no serious, acute or chronic eye diseases (eg glaucoma, advanced cataract, retinopathy, macular degeneration and peripheral retinal disease); refraction ( objectively and subjectively) spherical equivalent of -0.5 diopters to +0.75 diopters at a maximum cylinder of -1.0; clearly identifiable dominant eye; round, refractive and pupil centered on non-dominant eye, which at 315 Lux a pupil diameter between 2.5mm and 4.6mm measured using a Procyon of Haag-Streit adduced; central corneal thickness in the non-dominant eye is 500-650 micrometers; respondent currently used reading glasses for activities in near distances and has an uncorrected near visual aquity of 0.4 logMAR in the non- dominant eye; normal, clear cornea and normal tears;. 2000 endothelial cells / qmm; no pathological changes in retina (macula and optic nerve); no clinically significant dry eye

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Exclusion Criteria

Volunteers who already had an eye operation; professional groups such as truck drivers, pilots and drivers; all other points, which are listed under inclusion criteria and do not apply

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Addresses

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    • Neoptics AG
    • Mr.  Markus  Wipf 
    • Dammstrasse 19
    • CH-6301  Zug
    • Switzerland
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    • Klinik für Augenheilkunde, Goethe Universität Frankfurt am Main
    • Mr.  Oliver  Klaproth 
    • Theodor- Stern- Kai 7
    • 60590  Frankfurt am Main
    • Germany
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    • Klinik für Augenheilkunde, Goethe- Universität Frankfurt am Main
    • Ms.  Katarina  Pfeiffer 
    • Theodor- Stern- Kai 7
    • 60590  Frankfurt am Main
    • Germany
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Sources of Monetary or Material Support

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    • Neoptics AG
    • Mr.  Markus  Wipf 
    • Dammstrasse 19
    • 6301  Zug
    • Switzerland
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.