Vitreous DetachmentNCT03970148
YAG Laser Vitreolysis for Floaters
A study testing Nd: YAG laser in people with Vitreous Detachment, run by University Hospital of Split at 1 site in Croatia.
Trial summary
Vitreous fluid, containing 95% water, fills the space behind the lens. Its gelatinous consistency is due to the presence of hyaluronic acid, mucopolysaccharide and collagen fibers. With age, the collagen aggregates into parallel bundles, bound by cross links, leaving the pockets of liquid in the glass body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreous Detachment
- What is being tested?
- Nd: YAG laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 2 Apr 2019to 30 Dec 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Is able to give written informed consent to the procedure
- Patients with clinical symptoms of floaters and clinically confirmed diagnosis of opacity in the vitreous body.
Who cannot join
- Inability to tolerate the procedure
- Blurred anterior eye segment
- Cataract or Intraocular lens opacity
- Blurred posterior eye segment
- Active eye inflammation
- Iris synechiae
- Uncontrolled intraocular pressure elevation
- Peripheral retinal degeneration
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital of Split
Split, Hrvatska, 21000
Jelena Grubelic, ms., 021 556-402, ocna.klinika@kbsplit.hr
About this study
Official title: YAG Laser Vitreolysis of Symptomatic Vitreal Floaters
Vitreous fluid, containing 95% water, fills the space behind the lens. Its gelatinous consistency is due to the presence of hyaluronic acid, mucopolysaccharide and collagen fibers. With age, the collagen aggregates into parallel bundles, bound by cross links, leaving the pockets of liquid in the glass body. This redistribution is referred to as syneresis, which is found in 90% older than 40 years. After liquefaction, the vitreous enters the retroviral space and separates the posterior hyaloid membrane from the retina. When separating from the optical disk it forms an annular formation (Weiss ring) in front of the optical disc. These agglomerated collagen bundles (opacities) disperse the photons of light and are perceived by the patients as a "gray silhouette-like artifact". Two major interventions for these symptoms include Nd: YAG laser vitreolysis and vitrectomy. The less invasive method Nd: YAG laser increases the temperature of the opacity thus vaporizing them to smaller fragments that are easier to sediment onto the bottom of the vitreous cavity thereby relieving the symptoms.
- Conditions
- Vitreous Detachment
- Being tested
- Nd: YAG laser
- Medical subject headings
- Vitreous Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd: YAG laserProcedure or surgery
Before treatment an optical coherence tomography (OCT) scan of the macula is performed to monitor possible macular oedema. After application of anesthetic and midriatics drops, the patient is positioned on the chin and forhead support (ND: YAG laser). Then, a contact lens (panfundoscope) is filled with methylcellulose and placed on the cornea. The laser is focused on the opacity that is to be treated and the first laser stamp of an initial power of 3 mJ is applied. The measured direct effect will guide in further adjustment of the laser beam power to achieve the desired effect. After treatment, a single drop of corticosteroid is applied to the patient and an ocular patch is applied. On follow up days an OCT scan of the macula is performed to monitor possible side effects.
| Study group | Role | What they receive |
|---|---|---|
| Nd: YAG laser treatment | Experimental | Before treatment an optical coherence tomography (OCT) scan of the macula is performed to monitor possible macular oedema. After application of anesthetic and midriatics drops, the patient is positioned on the chin and forhead support (ND: YAG laser). Then, a contact lens (panfundoscope) is filled with methylcellulose and placed on the cornea. The laser is focused on the opacity that is to be treated and the first laser stamp of an initial power of 3 mJ is applied. The measured direct effect will guide in further adjustment of the laser beam power to achieve the desired effect. After treatment, a single drop of corticosteroid is applied to the patient and an ocular patch is applied. On follow up days an OCT scan of the macula is performed to monitor possible side effects. Receives: Procedure: Nd: YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with resolution of symptoms
Number of patients who reported resolution of symptoms after the treatment
Measured: 1 month
Secondary outcomes (3)
Macular Oedema Development rate
Rate of macular oedema development after the treatment
Measured: 1 month
Rate of treatment side effects
Rate of treatment side effects such as: retinal damage, retinal detachment, cataract...
Measured: 1 month
Retreatment rate
Number of treatment sessions needed for simptom resolution
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start2 Apr 2019
- Primary completion2 Oct 2019 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreous DetachmentStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Collaborators
- University of Split, School of Medicine
- Responsible party
- Principal investigator, Assist. prof. Ljubo Znaor, MD PhD, University Hospital of Split
- Investigators
- Ljubo Znaor, MD, PHD, Principal investigator, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970148
- Sponsor's protocol ID
- 2181-147-01/06/M.S.-19-2
- Status last verified
- Jun 2019
- First submitted
- 28 May 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- YAG Laser Vitreolysis of Symptomatic Vitreal Floaters
- ClinicalTrials.gov ID
- NCT03970148
- Acronym / sponsor ID
- 2181-147-01/06/M.S.-19-2
- Conditions
- Vitreous Detachment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Collaborators
- University of Split, School of Medicine
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 2 Oct 2019 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 31 May 2019 (actual)
- 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.
Vitreous fluid, containing 95% water, fills the space behind the lens. Its gelatinous consistency is due to the presence of hyaluronic acid, mucopolysaccharide and collagen fibers. With age, the collagen aggregates into parallel bundles, bound by cross links, leaving the pockets of liquid in the glass body. This redistribution is referred to as syneresis, which is found in 90% older than 40 years. After liquefaction, the vitreous enters the retroviral space and separates the posterior hyaloid membrane from the retina. When separating from the optical disk it forms an annular formation (Weiss ring) in front of the optical disc. These agglomerated collagen bundles (opacities) disperse the photons of light and are perceived by the patients as a "gray silhouette-like artifact". Two major interventions for these symptoms include Nd: YAG laser vitreolysis and vitrectomy. The less invasive method Nd: YAG laser increases the temperature of the opacity thus vaporizing them to smaller fragments that are easier to sediment onto the bottom of the vitreous cavity thereby relieving the symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nd: YAG laser treatment | Experimental | Procedure: Nd: YAG laserBefore treatment an optical coherence tomography (OCT) scan of the macula is performed to monitor possible macular oedema. After application of anesthetic and midriatics drops, the patient is positioned on the chin and forhead support (ND: YAG laser). Then, a contact lens (panfundoscope) is filled with methylcellulose and placed on the cornea. The laser is focused on the opacity that is to be treated and the first laser stamp of an initial power of 3 mJ is applied. The measured direct effect will guide in further adjustment of the laser beam power to achieve the desired effect. After treatment, a single drop of corticosteroid is applied to the patient and an ocular patch is applied. On follow up days an OCT scan of the macula is performed to monitor possible side effects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Is able to give written informed consent to the procedure
- Patients with clinical symptoms of floaters and clinically confirmed diagnosis of opacity in the vitreous body.
Key exclusion criteria (8 listed)
- Inability to tolerate the procedure
- Blurred anterior eye segment
- Cataract or Intraocular lens opacity
- Blurred posterior eye segment
- Active eye inflammation
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 |
|---|---|---|
| Nd: YAG laserBefore treatment an optical coherence tomography (OCT) scan of the macula is performed to monitor possible macular oedema. After application of anesthetic and midriatics drops, the patient is positioned on the chin and forhead support (ND: YAG laser). Then, a contact lens (panfundoscope) is filled with methylcellulose and placed on the cornea. The laser is focused on the opacity that is to be treated and the first laser stamp of an initial power of 3 mJ is applied. The measured direct effect will guide in further adjustment of the laser beam power to achieve the desired effect. After treatment, a single drop of corticosteroid is applied to the patient and an ocular patch is applied. On follow up days an OCT scan of the macula is performed to monitor possible side effects. | Procedure or surgery | Nd: YAG laser treatment |
Primary outcome
Number of patients with resolution of symptoms
Time frame: 1 month
Number of patients who reported resolution of symptoms after the treatment
3 secondary outcomes
Macular Oedema Development rate
Time frame: 1 month
Rate of treatment side effects
Time frame: 1 month
Retreatment rate
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Ljubo Znaor, MD, PHD principal investigator
University Hospital of Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nd: YAG laser in people with Vitreous Detachment, run by University Hospital of Split at 1 site in Croatia.
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 3 inclusion and 8 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 11 Jun 2019. 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 Croatia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Ljubo Znaor, MD, PHD (+385915052181 ext. +385989088286, ljuboznaor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with resolution of symptoms (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2019.