Other Vitreous Opacities, BilateralPhase 4EllexNCT02812004
New Horizons in the Treatment of Vitreous Floaters
A Phase 4 study testing Ultra Q Reflex YAG laser (Ellex) in people with Other Vitreous Opacities, Bilateral, run by Augenabteilung Allgemeines Krankenhaus Linz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Other Vitreous Opacities, Bilateral
- What is being tested?
- Ultra Q Reflex YAG laser (Ellex)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2016to Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Other Vitreous Opacities, Bilateral
- Being tested
- Ultra Q Reflex YAG laser (Ellex)
- Keywords
- Vitreous Floaters, Mouches Voulantes
- Medical subject headings
- vitreous floaters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Eye | Experimental | Ultra Q Reflex YAG laser (Ellex) Receives: Device: Ultra Q Reflex YAG laser (Ellex) |
| Contralateral Eye | Sham comparator | Short light impulse is simulated Receives: Device: Ultra Q Reflex YAG laser (Ellex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility Value Score
Subjective Assessment of Impairment due to floaters
Measured: 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Other Vitreous Opacities, BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augenabteilung Allgemeines Krankenhaus Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Ring, Dr, Study director, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812004
- Sponsor's protocol ID
- AO Form 01-05/1.0 - Ellex
- Acronym
- Ellex
- Status last verified
- Jul 2016
- First submitted
- 17 Jun 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 3754829Tassignon 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.
PubMed 1841668Delaney 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.
PubMed 11913884Cowan 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.
PubMed 25308785Abdelkawi 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.
PubMed 23797611
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Horizons in the Treatment of Vitreous Floaters: Efficacy and Safety of Vitreolysis With the Ultra Q Reflex YAG Laser (Ellex)
- ClinicalTrials.gov ID
- NCT02812004
- Acronym / sponsor ID
- Ellex / AO Form 01-05/1.0 - Ellex
- Conditions
- Other Vitreous Opacities, Bilateral
- Keywords
- Vitreous Floaters, Mouches Voulantes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Augenabteilung Allgemeines Krankenhaus LinzUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Eye | Experimental | Device: Ultra Q Reflex YAG laser (Ellex)Ultra Q Reflex YAG laser (Ellex) |
| Contralateral Eye | Sham comparator | Device: Ultra Q Reflex YAG laser (Ellex)Short light impulse is simulated |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Contralateral Eye, Study Eye |
Primary outcome
Utility Value Score
Time frame: 1-6 months
Subjective Assessment of Impairment due to floaters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Background: PubMed 3754829Little 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.
- Background: PubMed 1841668Tassignon 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.
- Background: PubMed 11913884Delaney 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.
- Background: PubMed 25308785Cowan 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.
- Background: PubMed 23797611Abdelkawi 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.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Ring, Dr study director
Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ultra Q Reflex YAG laser (Ellex) in people with Other Vitreous Opacities, Bilateral, run by Augenabteilung Allgemeines Krankenhaus Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Bolz, Dr (+4373278061944, matthias.bolz@akh.linz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility Value Score (time frame: 1-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02812004, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.