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New Horizons in the Treatment of Vitreous Floaters (Ellex)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812004
Recruitment Status : Unknown
Verified July 2016 by Augenabteilung Allgemeines Krankenhaus Linz.
Recruitment status was:  Not yet recruiting
First Posted : June 23, 2016
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Augenabteilung Allgemeines Krankenhaus Linz

Brief Summary:

The Ultra Q Reflex® (Ellex) constitutes the only Nd:YAG laser approved for the treatment of vitreous floaters. No randomized controlled clinical trial has been carried out to this day in order to investigate its superiority over sham treatment.

In the present study, 60 eyes will be randomized and blinded into 2 groups, one receiving up to two sessions of laser vitreolysis the other scheduled for two sessions of sham treatment. After a maximum of two (sham) treatment sessions (1 per month), patients' utility value score and BCVA will be re-assessed. A follow-up period of 12 months (with visits at month 1, 6 and 12 post-treatment) will ensue the "treatment phase" to register any late adverse events that may be associated with laser vitreolysis.

As vitrectomy constitutes a highly invasive procedure, which must therefore be restricted to severe cases only, laser vitreolysis may present a valuable treatment option for patients with moderate vitreous floaters that are not eligible for vitrectomy.


Condition or disease Intervention/treatment Phase
Other Vitreous Opacities, Bilateral Device: Ultra Q Reflex YAG laser (Ellex) Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: New Horizons in the Treatment of Vitreous Floaters: Efficacy and Safety of Vitreolysis With the Ultra Q Reflex YAG Laser (Ellex)
Study Start Date : July 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : October 2017

Arm Intervention/treatment
Experimental: Study Eye
Ultra Q Reflex YAG laser (Ellex)
Device: Ultra Q Reflex YAG laser (Ellex)

Group 1 receives up to 2 sessions of vitreolysis performed with the Ultra Q Reflex YAG laser (Ellex). There is no cut off for total energy per treatment session.

For the sham treatment in group 2, the physician quickly manipulates the light switch of the laser's slit lamp to create light flashes and simulate laser pulses.


Sham Comparator: Contralateral Eye
Short light impulse is simulated
Device: Ultra Q Reflex YAG laser (Ellex)

Group 1 receives up to 2 sessions of vitreolysis performed with the Ultra Q Reflex YAG laser (Ellex). There is no cut off for total energy per treatment session.

For the sham treatment in group 2, the physician quickly manipulates the light switch of the laser's slit lamp to create light flashes and simulate laser pulses.





Primary Outcome Measures :
  1. Utility Value Score [ Time Frame: 1-6 months ]
    Subjective Assessment of Impairment due to floaters



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • the subject's written consent to participate in the present study
  • considerable impairment of quality of life (defined as utility value score ≤ 0.7) due to floater-related symptoms for at least 3 months prior to inclusion
  • floaters must be located at a safe distance to both the retina and the intraocular lens - preferably in the middle third of the vitreous
  • pseudophakic eyes
  • age >18 years

Exclusion Criteria:

  • phakic eyes
  • any retinal pathology and/or other ocular condition (including but not limited to amblyopia, pathologies of the cornea, glaucoma/history of elevated intraocular pressure) that may prevent or reduce a potential increase in visual acuity and/or decrease of the utility value score and/or incur an increased likelihood of adverse events.
  • any ocular or systemic condition that may result in an impaired feasibility of the study treatment and/or required examinations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812004


Contacts
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Contact: Matthias Bolz, Dr +4373278061944 matthias.bolz@akh.linz.at
Contact: Michael Ring, Dr +4373278061944 michael.ring@akh.linz.at

Locations
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Austria
AKh Linz
Linz, Oberösterreich, Austria, 4021
Sponsors and Collaborators
Augenabteilung Allgemeines Krankenhaus Linz
Investigators
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Study Director: Michael Ring, Dr Department of Ophthalmology
Publications:
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Responsible Party: Augenabteilung Allgemeines Krankenhaus Linz
ClinicalTrials.gov Identifier: NCT02812004    
Other Study ID Numbers: AO Form 01-05/1.0 - Ellex
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Augenabteilung Allgemeines Krankenhaus Linz:
Vitreous Floaters
Mouches Voulantes