Sub-threshold Micro-Pulse Laser Therapy for Drusen of Dry... | NCT03968575

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

NCT03968575

Sponsor

The Eye Hospital of Wenzhou Medical University

Status

Unknown status

Last Update Posted

Feb 24, 2021Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Drusen

Interventions

laser treatment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Apr 30, 2021Estimated

Completion Date

Apr 30, 2022Estimated

First Submitted Date

May 22, 2019

First Submission Date that Met QC Criteria

May 27, 2019

First Posted Date

May 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2021

Last Update Posted Date

Feb 24, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaoling Liu, Clinical Professor, The Eye Hospital of Wenzhou Medical UniversityPrincipal Investigator

Lead Sponsor

The Eye Hospital of Wenzhou Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laser	Experimental		Device: laser treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laser treatment	Device	sub-threshold micro-pulse laser treatment	Laser

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ying Huang	Contact	0577-88068855		wzhuangying@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The eye of Wenzhou Medical University	Recruiting	Wenzhou	Zhejiang	325000	China

Intervention Browse Module

MeSH Terms

ID	Term
D053685	Laser Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided