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

Drusen Clinical Trial

Official title:

The Affiliated Eye Hospital of Wenzhou Medical University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03968575
• Other study ID #: 2019-075-K-74
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: February 2021
• Source: The Eye Hospital of Wenzhou Medical University
• Contact: Ying Huang
• Phone: 0577-88068855
• Email: wzhuangying[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drusen

Intervention

Device:
• laser treatment
sub-threshold micro-pulse laser treatment

Locations

Country	Name	City	State
China	The eye of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Eye Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in macular drusen volume	Mean change in macular drusen volume on optical coherence tomograph(OCT)	6 and 12 months
Primary	Change in macular drusen area	Mean change in macular drusen area on OCT	6 and 12 months
Secondary	Change in visual acuity	Mean change in best-corrected visual acuity	6 and 12 months