YAG Laser Vitreolysis for Floaters

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.

Study Overview

• Status: Unknown
• Conditions: Vitreous Detachment
• Intervention / Treatment: Procedure: Nd: YAG laser

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Hrvatska
    • Split, Hrvatska, Croatia, 21000
      • Recruiting
      • University Hospital of Split
      • Contact: Jelena Grubelic, ms.; Phone Number: 021 556-402; Email: ocna.klinika@kbsplit.hr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Nd: YAG laser treatment; 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.

Procedure: Nd: YAG laser; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with resolution of symptoms	Number of patients who reported resolution of symptoms after the treatment	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular Oedema Development rate	Rate of macular oedema development after the treatment	1 month
Rate of treatment side effects	Rate of treatment side effects such as: retinal damage, retinal detachment, cataract...	1 month
Retreatment rate	Number of treatment sessions needed for simptom resolution	1 month

Collaborators and Investigators

• Sponsor: University Hospital of Split
• Collaborators: University of Split, School of Medicine
• Investigators: Principal Investigator: Ljubo Znaor, MD, PHD, University Hospital of Split

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Anticipated): October 2, 2019
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Vitreous Detachment
• Other Study ID Numbers: 2181-147-01/06/M.S.-19-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No