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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03968575
Other study ID # 2019-075-K-74
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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