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

Sponsor
The Eye Hospital of Wenzhou Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03968575
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
37
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: laser treatment
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Affiliated Eye Hospital of Wenzhou Medical University
Actual Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
Apr 30, 2021
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Laser

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

Outcome Measures

Primary Outcome Measures

  1. Change in macular drusen volume [6 and 12 months]

    Mean change in macular drusen volume on optical coherence tomograph(OCT)

  2. Change in macular drusen area [6 and 12 months]

    Mean change in macular drusen area on OCT

Secondary Outcome Measures

  1. Change in visual acuity [6 and 12 months]

    Mean change in best-corrected visual acuity

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The eye of Wenzhou Medical University Wenzhou Zhejiang China 325000

Sponsors and Collaborators

  • The Eye Hospital of Wenzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiaoling Liu, Clinical Professor, The Eye Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT03968575
Other Study ID Numbers:
  • 2019-075-K-74
First Posted:
May 30, 2019
Last Update Posted:
Feb 24, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 24, 2021