YAG Laser Vitreolysis for Floaters

Vitreous Detachment Clinical Trial

Official title:

YAG Laser Vitreolysis of Symptomatic Vitreal Floaters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03970148
• Other study ID #: 2181-147-01/06/M.S.-19-2
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2019
• Source: University Hospital of Split
• Contact: Ljubo Znaor, MD, PHD
• Phone: +385915052181
• Email: ljuboznaor[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2020
• Est. primary completion date: October 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vitreous Detachment

Intervention

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.

Locations

Country	Name	City	State
Croatia	University Hospital of Split	Split	Hrvatska

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Split	University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with resolution of symptoms	Number of patients who reported resolution of symptoms after the treatment	1 month
Secondary	Macular Oedema Development rate	Rate of macular oedema development after the treatment	1 month
Secondary	Rate of treatment side effects	Rate of treatment side effects such as: retinal damage, retinal detachment, cataract...	1 month
Secondary	Retreatment rate	Number of treatment sessions needed for simptom resolution	1 month