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YAG Laser Vitreolysis for Floaters

Primary Purpose

Vitreous Detachment

Status
Unknown status
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Nd: YAG laser
Sponsored by
University Hospital of Split
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitreous Detachment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • University Hospital of SplitRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nd: YAG laser treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of patients with resolution of symptoms
Number of patients who reported resolution of symptoms after the treatment

Secondary Outcome Measures

Macular Oedema Development rate
Rate of macular oedema development after the treatment
Rate of treatment side effects
Rate of treatment side effects such as: retinal damage, retinal detachment, cataract...
Retreatment rate
Number of treatment sessions needed for simptom resolution

Full Information

First Posted
May 28, 2019
Last Updated
June 6, 2019
Sponsor
University Hospital of Split
Collaborators
University of Split, School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03970148
Brief Title
YAG Laser Vitreolysis for Floaters
Official Title
YAG Laser Vitreolysis of Symptomatic Vitreal Floaters
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2, 2019 (Actual)
Primary Completion Date
October 2, 2019 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Split
Collaborators
University of Split, School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreous Detachment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nd: YAG laser treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Nd: YAG laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients with resolution of symptoms
Description
Number of patients who reported resolution of symptoms after the treatment
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Macular Oedema Development rate
Description
Rate of macular oedema development after the treatment
Time Frame
1 month
Title
Rate of treatment side effects
Description
Rate of treatment side effects such as: retinal damage, retinal detachment, cataract...
Time Frame
1 month
Title
Retreatment rate
Description
Number of treatment sessions needed for simptom resolution
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ljubo Znaor, MD, PHD
Phone
+385915052181
Ext
+385989088286
Email
ljuboznaor@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ante Basic, MD
Phone
+385989088286
Ext
+385989088286
Email
ante.basic1@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ljubo Znaor, MD, PHD
Organizational Affiliation
University Hospital of Split
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Split
City
Split
State/Province
Hrvatska
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jelena Grubelic, ms.
Phone
021 556-402
Email
ocna.klinika@kbsplit.hr

12. IPD Sharing Statement

Plan to Share IPD
No

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YAG Laser Vitreolysis for Floaters

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