YAG Laser Vitreolysis for Floaters

NCT03970148 | Unknown

• 1 other identifier: 2181-147-01/06/M.S.-19-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitreous Detachment

Outcome Measures

Primary Outcomes (1)

• Number of patients with resolution of symptoms

  Number of patients who reported resolution of symptoms after the treatment

  1 month

Secondary Outcomes (3)

• Macular Oedema Development rate

  1 month

• Rate of treatment side effects

  1 month

• Retreatment rate

  1 month

Study Arms (1)

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.

Procedure: Nd: YAG laser

Interventions

Nd: YAG laser PROCEDURE

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.

Nd: YAG laser treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Split: lead
• University of Split, School of Medicine: collaborator

Study Sites (1)

University Hospital of Split

Split, Hrvatska, 21000, Croatia

RECRUITING

MeSH Terms

Conditions

Vitreous Detachment

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Ljubo Znaor, MD, PHD

  University Hospital of Split

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ljubo Znaor, MD, PHD

CONTACT

+385915052181; ljuboznaor@gmail.com

Ante Basic, MD

CONTACT

+385989088286; ante.basic1@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 31, 2019
• Study Start: April 2, 2019
• Primary Completion: October 2, 2019
• Study Completion: December 30, 2020
• Last Updated: June 11, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)