Two Patterns of Micropulse Laser in the Treatment of Chronic Central Serous Chorioretinopathy

January 13, 2023 updated by: Yu Xiaobing, Beijing Hospital

A Randomized Controlled Study of Two Patterns of Micropulse Laser in the Treatment of Chronic Central Serous Chorioretinopathy

Central serous chorioretinopathy (CSC) is a common eye disease mainly involving the macular area, causing central visual acuity loss. Recently, subthreshold micropulse laser used in treating chronic CSC is proved to be safe and effective. However, some studies indicate that it's less effective than half dose photodynamic therapy (PDT). Certain physicians, including us, think that this may be related to micropulse laser parameters. Thus we need to explore better laser patterns to replace PDT in treating chronic CSC. The aim of this study is to compare the treatment effect of two different patterns of laser parameters (small and regular spot diameter) in treating chronic CSC. In this randomized, double blinded, controlled trial, by comparing the subretinal fluid regression ratio, central retinal thickness, macular microvisual field, macular vascular density, chroidal volume changes and visual acuity of two groups 6 months after micropulse laser treatment, we aim to evaluate the safety and efficacy of refined micropulse laser in treating chronic CSC.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients age range 18-50 years
  • Patients diagnosed with chronic Central serous chorioretinopathy
  • Patients have signed informed consent

Exclusion Criteria:

  • A history of other fundus diseases or refractive media opacity
  • Patients have underwent other treatment methods for chronic Central serous chorioretinopathy
  • Diopter>-6D
  • A history of system diseases such as hypertension or diabetes
  • A history of using local or systemic corticosteroids

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 100μm laser spot diameter group
Procedure: 100μm laser spot diameter micropulse laser
100μm laser spot diameter micropulse laser at baseline, then follow-up for 6 months
Active Comparator: 200μm laser spot diameter group
Procedure: 200μm laser spot diameter micropulse laser
200μm laser spot diameter micropulse laser at baseline, then follow-up for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subretinal fluid regression ratio
Time Frame: 6 months
Comparing the subretinal fluid regression ratio of two groups at 6 months follow-up
6 months
Central retinal thickness changes
Time Frame: 6 months
Comparing the central retinal thickness changes of two groups at 6 months
6 months

Collaborators and Investigators

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

Sponsor

Beijing Hospital

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 (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 25, 2022

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-I2M-C&T-B-093

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.

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