Sub-threshold Micro-Pulse Laser Therapy for Drusen of Dry AMD

Not Applicable

• Conditions: Drusen
• Interventions: Device: laser treatment

• Registration Number: NCT03968575
• Lead Sponsor: The Eye Hospital of Wenzhou Medical University

Brief Summary

To investigate the efficacy and safety of sub-threshold micro-pulse laser therapy for drusen of dry age-related macular degeneration (AMD) .

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24
• Primary Completion: 2021-04-30
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Older than 50 years of age.
2. Male or female patients with nonexudative AMD with a drusen diameter of at least 125um in the central 3mm circle
3. clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT.
4. Able to give an informed consent.

Exclusion Criteria

1. Presence of other macular disease such as epiretinal membrane, macular telangiectasia.
2. unclear media that no clear colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT can performed.
3. Ocular or periocular infections.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser	laser treatment	-

Primary Outcome Measures

Name	Time	Method
Change in macular drusen volume	6 and 12 months	Mean change in macular drusen volume on optical coherence tomograph(OCT)
Change in macular drusen area	6 and 12 months	Mean change in macular drusen area on OCT

Secondary Outcome Measures

Name	Time	Method
Change in visual acuity	6 and 12 months	Mean change in best-corrected visual acuity

Trial Locations

Locations (1)

The eye of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China