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

February 23, 2021 updated by: Xiaoling Liu, The Eye Hospital of Wenzhou Medical University

The Affiliated Eye Hospital of Wenzhou Medical University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The eye of Wenzhou Medical University
        • Principal Investigator:
          • Xiaoling Liu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser
Device: laser treatment
sub-threshold micro-pulse laser treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in macular drusen volume
Time Frame: 6 and 12 months
Mean change in macular drusen volume on optical coherence tomograph(OCT)
6 and 12 months
Change in macular drusen area
Time Frame: 6 and 12 months
Mean change in macular drusen area on OCT
6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual acuity
Time Frame: 6 and 12 months
Mean change in best-corrected visual acuity
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Eye Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

April 30, 2021

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

May 22, 2019

First Submitted That Met QC Criteria

May 27, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-075-K-74

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Drusen

Clinical Trials on laser treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe