New Horizons in the Treatment of Vitreous Floaters (Ellex)

July 11, 2016 updated by: Augenabteilung Allgemeines Krankenhaus Linz

New Horizons in the Treatment of Vitreous Floaters: Efficacy and Safety of Vitreolysis With the Ultra Q Reflex YAG Laser (Ellex)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A great number of patients seek out their ophthalmologists when troubled by vitreous floaters. The majority of these patients are reassured when the diagnosis is made and are content to get accustomed to these "mouches volantes". A considerable proportion, however, feels permanently irritated by vitreous floaters which may result in a significant decrease of patients' quality of life.

Until recently, pars plana vitrectomy constituted the only established therapeutic option. Though a standard surgical procedure, the potential adverse events associated with vitrectomy are not negligible and patients must allow for an extended period of visual rehabilitation. Therefore, treatment was restricted to severe cases and thus only a very small percentage of patients received any treatment at all.

Reports exist on Q-switched Nd:YAG laser surgery for vitreous opacities, membranes and vitreoretinal bands in 59 eyes. The results of early laser vitreolysis are sobering with an improve in visual acuity in only 18 eyes but considerable adverse events such as retinal holes with detachment (1 eye), minor retinal hemorrhages (4 eyes) and focal opacities of the crystalline lens (5 eyes).

According to another study, the Q-switched system allowed treatment of a wider variety of indications in the posterior pole and requires fewer sessions when compared to a mode-locked system. Due to the higher energy levels required by Q-switch system, however, complications occurred more frequently.

An additional study presented more favorable results; in all 15 cases the symptoms of vitreous floaters disappeared after treatment and no adverse events were reported during a follow-up period of at least 1 year. Nevertheless, the reported energy levels (5-7.1mJ and total energy 71-742mJ) were considerable.

Further results suggested that laser vitreolysis moderately improved symptoms in 38% of all patients, while 61,5% registered no improvement; no adverse events were reported. In contrast, vitrectomy resulted in full resolution of symptoms in 93,3% of eyes - with one patient suffering post-operative retinal detachment.

A recent study presented 3 cases of chronic open-angle glaucoma secondary to ND:YAG vitreolysis (3 eyes of 2 patients). The latency period between vitreolysis and onset of elevated IOP ranged from 1 week to 8 months; other potential factors promoting a rise in IOP, namely "inflammation, steroid use, or other identifiable causes" are reported as absent. In two eyes, SLT followed by glaucoma surgery (Trabectome) was required to stabilise IOP.

Whereas the treatment of floaters located in the anterior vitreous resulted in no obvious change, treatment in the mid-vitreous and posterior vitreous lead to an increase in protein, the refractive index and the viscosity of the vitreous humor.

It appears that the current literature remains inconclusive as to the efficacy and safety of Nd:YAG vitreolysis. In the review literature, floater vitrectomy - especially with small sutureless gauge instruments and a corevitrectomy - yields excellent success rates combined with a low risk profile. In contrast, the efficacy of vitreolysis ranges between 0 and 100%. The key factor to success in vitreolysis is the use of appropriately high energy levels and the application of a sufficient amount of shots. In his retrospective, observational study (including 168 eyes, treatment with the Ultra Q Relfex®) 92% of patients were satisfied with the result;

In the present study, vitreolysis is performed with the Ultra Q Reflex® laser - to this day the only laser officially approved for vitreolysis. It features an ultra-Gaussian beam mode, teamed with a fast-pulse rise time and a small-spot size. Due to the tightly controlled plasma with its higher power density fewer shots are required which results in a lower cumulative dose. Moreover, the co-axial alignment of the practitioner's vision, the target illumination, and the treatment beam grants better illumination of vitreous opacities and thus allows for more precise focusing. This patented design facilitates the vaporization of floaters and minimizes the risk of collateral damage to adjacent tissues.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4021
        • AKH Linz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 105 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utility Value Score
Time Frame: 1-6 months
Subjective Assessment of Impairment due to floaters
1-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augenabteilung Allgemeines Krankenhaus Linz

Investigators

  • Study Director: Michael Ring, Dr, Department of Ophthalmology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AO Form 01-05/1.0 - Ellex

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Other Vitreous Opacities, Bilateral

Clinical Trials on Ultra Q Reflex YAG laser (Ellex)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe