New Horizons in the Treatment of Vitreous Floaters

NCT02812004 | Unknown Phase 4

• 1 other identifier: AO Form 01-05/1.0 - Ellex
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Other Vitreous Opacities, Bilateral

Keywords

Vitreous Floaters; Mouches Voulantes

Outcome Measures

Primary Outcomes (1)

• Utility Value Score

  Subjective Assessment of Impairment due to floaters

  1-6 months

Study Arms (2)

Study Eye

EXPERIMENTAL

Ultra Q Reflex YAG laser (Ellex)

Device: Ultra Q Reflex YAG laser (Ellex)

Contralateral Eye

SHAM COMPARATOR

Short light impulse is simulated

Device: Ultra Q Reflex YAG laser (Ellex)

Interventions

Ultra Q Reflex YAG laser (Ellex) DEVICE

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.

Contralateral Eye; Study Eye

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the subject's written consent to participate in the present study
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Augenabteilung Allgemeines Krankenhaus Linz: lead

Study Sites (1)

AKh Linz

Linz, Upper Austria, 4021, Austria

Location

Related Publications (5)

• Little HL, Jack RL. Q-switched neodymium: YAG laser surgery of the vitreous. Graefes Arch Clin Exp Ophthalmol. 1986;224(3):240-6. doi: 10.1007/BF02143063.

  PMID: 3754829 BACKGROUND

• Tassignon MJ, Kreissig I, Stempels N, Brihaye M. Indications for Q-switched and mode-locked Nd: YAG lasers in vitreoretinal pathology. Eur J Ophthalmol. 1991 Jul-Sep;1(3):123-30. doi: 10.1177/112067219100100304.

  PMID: 1841668 BACKGROUND

• Delaney YM, Oyinloye A, Benjamin L. Nd:YAG vitreolysis and pars plana vitrectomy: surgical treatment for vitreous floaters. Eye (Lond). 2002 Jan;16(1):21-6. doi: 10.1038/sj.eye.6700026.

  PMID: 11913884 BACKGROUND

• Cowan LA, Khine KT, Chopra V, Fazio DT, Francis BA. Refractory open-angle glaucoma after neodymium-yttrium-aluminum-garnet laser lysis of vitreous floaters. Am J Ophthalmol. 2015 Jan;159(1):138-43. doi: 10.1016/j.ajo.2014.10.006. Epub 2014 Oct 13.

  PMID: 25308785 BACKGROUND

• Abdelkawi SA, Abdel-Salam AM, Ghoniem DF, Ghaly SK. Vitreous humor rheology after Nd:YAG laser photo disruption. Cell Biochem Biophys. 2014 Mar;68(2):267-74. doi: 10.1007/s12013-013-9706-5.

  PMID: 23797611 BACKGROUND

MeSH Terms

Conditions

vitreous floaters

Study Officials

• Michael Ring, Dr

  Department of Ophthalmology

  STUDY DIRECTOR

Central Study Contacts

Matthias Bolz, Dr

CONTACT

+4373278061944; matthias.bolz@akh.linz.at

Michael Ring, Dr

CONTACT

+4373278061944; michael.ring@akh.linz.at

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 23, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 12, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)