YAG Laser Vitreolysis for Floaters

NCT ID: NCT03970148

Last Updated: 2019-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2020-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nd: YAG laser

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Split, School of Medicine

OTHER

Sponsor Role: collaborator

University Hospital of Split

OTHER

Sponsor Role: lead

Responsible Party

Assist. prof. Ljubo Znaor, MD PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ljubo Znaor, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Split

Locations

University Hospital of Split

Split, Hrvatska, Croatia

Site Status: RECRUITING

Countries

Croatia

Central Contacts

Ljubo Znaor, MD, PHD

Role: CONTACT

ljuboznaor@gmail.com

+385915052181 ext. +385989088286

Ante Basic, MD

Role: CONTACT

ante.basic1@hotmail.com

+385989088286 ext. +385989088286

Facility Contacts

Jelena Grubelic, ms.

Role: primary

ocna.klinika@kbsplit.hr

021 556-402

Other Identifiers

2181-147-01/06/M.S.-19-2

Identifier Type: -

Identifier Source: org_study_id