Trial document





This trial has been registered retrospectively.
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  DRKS00015316

Trial Description

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Title

Refractive Accuracy and Rotational stability with an Aspheric Toric Intraocular Lens With and Without Implantation of a Capsular Tension Ring
- a randomized two parallel arms clinical trial -

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Trial Acronym

tIOL / CTR Studie

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients having a corneal irregularity (astigmatism) may benefit from so called toric intraocular lens (tIOL). The tIOL has to be implanted instead of the body’s own lens into capsule bag. The correct and stable position of the tIOL is key for compensating the corneal irregularity. A possible influence of implantation of a so called capsular tension ring (CTR) on rotational stability has been subject to discussions. The purpose of this study is to investigate in patient groups with and without CTR the resulting refractive deficit and the rotation of the tIOL three month after surgery.

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Brief Summary in Scientific Language

In this study a possible influence of implantation of a capsular tension ring on refractive accuracy and rotational stability with a toric IOL was investigated.

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Organizational Data

  •   DRKS00015316
  •   2018/08/27
  •   [---]*
  •   yes
  •   Approved
  •   2013-373-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   H25.0 -  Senile incipient cataract
  •   H52.2 -  Astigmatism
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Interventions/Observational Groups

  •   Patients with senile cataract and astimatism receiving a toric intraocular lens - WITHOUT simultaneous implantation of a capsular tension ring
  •   Patients with senile cataract and astimatism receiving a toric intraocular lens - WITH simultaneous implantation of a capsular tension ring
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

maximum absolute difference of 0.5 D between preoperatively calculated and achieved cylinder, emerged three months after implantation or at time of a revision [yes / no]

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Secondary Outcome

absolute total IOL rotation of 5° or less immediately after implantation (horizontal position) versus three months afterwards or at time of a revision [yes / no]

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/05/20
  •   212
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- intended implantation of Tecnis Toric in one or both eyes - age-related cataract with regular astigmatism - requiring an IOL power between 16.0 and 26.0 D SEQ - intended and reasonable ambulant cataract surgery - age 18 and older - regular astigmatism with a corneal cylinder between 0.75 and -2.75 D - patients with a post-operative potential best-corrected visual acuity of 0.5 or better based on the estimation of the surgeon - written informed consent to surgery, participation in the study and data protection

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Exclusion Criteria

- the partner eye was already recruited - relevant concomitant ophthalmic diseases (such as significant cornea guttata, significant corneal scar/opacity, glaucoma, NPDR stage II or II, PDR, pseudoexfoliation, trauma, AMD and other co-morbidity that could result in an outcome worse than UCVA 0.5 or that might affect capsular bag stability) - history of relevant previous ocular surgery (such as corneal surgery, glaucoma surgery, vitreoretinal surgery, other surgery) which might result in an outcome worse than UCVA 0.5 or that might affect capsular stability - expected residual cylinder ≥ 0,5 dpt - Patient participates in other clinical trials

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Addresses

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    • OcuNet GmbH & Co KG
    • Dr. rer. medic.  Ursula  Hahn 
    • Friedrichstraße 37
    • 40217  Düsseldorf
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Institut für Medizinische Biometrie und Epidemiologie; Fakultät für Gesundheit der Universität Witten/Herdecke
    • Prof. Dr. rer. nat. et med. habil.  Frank  Kummenauer 
    • Alfred-Herrhausen-Straße 50
    • 58448  Witten/Herdecke
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    • Augen-Zentrum-Nordwest
    • Dr. med.  Stefanie  Schmickler 
    • Domhof 15
    • 48683  Ahaus
    • Germany
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    • OcuNet GmbH & Co KG
    • Ms.  Dr. rer. medic.  Ursula  Hahn 
    • Friedrichstraße 47
    • 40217  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Johnson & Johnson Vision, früher Abbott Medical Optics (AMO)
    • Rudolf-Plank-Straße 31
    • 76275  Ettlingen
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2016/06/18
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* This entry means the parameter is not applicable or has not been set.