YAG Laser Vitreolysis for Floaters

Not Applicable

• Conditions: Vitreous Detachment

• Registration Number: NCT03970148
• Lead Sponsor: University Hospital of Split

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-02
• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-11
• Primary Completion: 2019-10-02
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients with resolution of symptoms	1 month	Number of patients who reported resolution of symptoms after the treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Split; 🇭🇷 Split, Hrvatska, Croatia