Trial document





This trial has been registered retrospectively.
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  DRKS00010932

Trial Description

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Title

Application study with the light-adjustable intraocular lens LAL

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Trial Acronym

LAL

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to Show the performance in terms of the vision after surgery.
With the surgery, the natural lens is removed and replaced by an artificial intraocular lens, which can be adjusted by light, in order to improve vision.

The adjustment of the IOL to the target refraction (refraction) takes place one week after the Surgery. Should further adjustments (fine adjustment) be necessary, this will be carried out after an additional week. The final stabilization of the lens will take place 3 days after the fine adjustment. In the period until the final stabilization of the lens a UV-safety-glasses must be worn.
At the follow-up visits at week 2, 1 month, month 3, month 6 and month 12 after the surgery, the visual acuity, the intraocular pressure will be checked and an examination of the eyes with slit lamp will be done.
To check the quality of the artificial lens (IOL), the ability to read, the contrast sensitivity, glare sensitivity and reflections of the lens will be measured.

In this study, patients will be enrolled with a minimum age of 18 years of both sexes.

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Brief Summary in Scientific Language

The light-adjustable intraocular lens (LAL) is implanted in patients suffering from a cataract. A cataract Formation can be caused by age (cataracta senilis), congenital (cataracta congenita), or by an accident (cataracta traumatica). The LAL is used for the permanent replacement of the natural lens after surgical removal of the crystalline lens through ultrasound energy through a microincision of the cornea of ​​3.0 mm width. After the implantation of the LAL into the capsule bag, the individual setting of the refractive power of the lens is performed by short-term irradiation with UV light. At a wavelength of 365 nm, a polymerisation of silicone monomers is partly effected in the lens. The subsequent redistribution of remaining monomers along the density gradient in the LAL leads to a defined swelling of the LAL in the irradiated parts with the consequence of a change in the refractive power. This process can be carried out several times until the subjectively desired refractive power of the LAL is reached. Finally, the LAL is again irradiated with UV light in order to polymerize all remaining silicone monomers in the intraocular lens and to permanently fix the lens with the correct refractive power (lock-in).

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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

  •   DRKS00010932
  •   2017/01/16
  •   [---]*
  •   yes
  •   Approved
  •   3240-08, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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Health Condition or Problem studied

  •   H25.0 -  Senile incipient cataract
  •   H25.1 -  Senile nuclear cataract
  •   H25.2 -  Senile cataract, morgagnian type
  •   H25.8 -  Other senile cataract
  •   H25.9 -  Senile cataract, unspecified
  •   Q12.0 -  Congenital cataract
  •   H26.0 -  Infantile, juvenile and presenile cataract
  •   H26.1 -  Traumatic cataract
  •   H52.2 -  Astigmatism
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Interventions/Observational Groups

  •   Phacoemulsification with implantation of studylens (Light Adjustable Lens, LAL; Calhoun Vision Inc.) with subsequent adjustment of the refraction using UV light
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Uncorrected distance visual acuity by standard method (vision chart) on day 1, week 2 postoperatively (Lens is still variable by UV light); and at week 2, month 6, month 12 after LockIn (Lens can not be changed even by UV light)

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Secondary Outcome

at
Week 2 postoperative week 2, month 1, month 3, month 6, month 12 post LockIn:

- Best corrected visual acuity by standard method (Visus-charts)
- Refraction by standard method
- Corneal keratometry using Scheinpflug-Camera
- Intraocular pressure using I-Care tonometer

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2008/07/18
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

• patients with age-related cataract, in which the natural lens has been removed by using of phacoemulsification by circular capsulorhexis of the anterior lens capsule. The posterior capsule is intraoperatively opened by a capsulorhexis to insert the lens optics in this opening
• Primary implantation of intraocular lens
• patients with an anticipated visual acuity of 0.5 or better on the clinical investigation
• patients with normal anterior segment

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Exclusion Criteria

• already pre-existing pathological or physiological conditions, which can be degraded by the implantation of the intraocular lens, or may in the future can cause a decrease in visual acuity to 0.66, or worse. This also includes the findings indicated below and diagnoses:
• - microphthalmos
• - corneal dystrophies and endothelial pathologies
• - pseudoexfoliation lentis
• - High myopia
• - pars Planitis
• patients with corneal astigmatism, which is greater than one Diopter preoperative
• patients undergoing laser treatment of the retina is required
• Previous surgery on the cornea or intraocular surgery
• Condition after uveitis,
• Glaucoma, Diabetes mellitus with or without retinal involvement, age-related macular degeneration with the possibility of postoperative corrected visual acuity of 0.5 or better to deteriorate
• to fix Intraoperative complications such as rupture of the posterior capsule, zonulolysis, incomplete capsulorhexis, serious injury to the cornea or iris with the lack of opportunity, the lens at the intended location
• taking medications which have ocular side effects
• Patients who are already involved in other observational studies or trials
• one-eyed or functionally one-eyed patients
• Patients who do not appear to controls during the follow-up of 6 months or uncooperative are
• Children under 18 years

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Addresses

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Sources of Monetary or Material Support

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    • Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH Augenklinik
    • Mr.  Univ.-Prof. Dr. med.  H. Burkhard  Dick 
    • In der Schornau 23-25
    • 44892  Bochum
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/06/30
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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.