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

Sponsor
Beijing Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05687422
Collaborator
(none)
50
Enrollment
2
Arms
10.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 100μm laser spot diameter micropulse laser
  • Procedure: 200μm laser spot diameter micropulse laser
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Study of Two Patterns of Micropulse Laser in the Treatment of Chronic Central Serous Chorioretinopathy
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Subretinal fluid regression ratio [6 months]

    Comparing the subretinal fluid regression ratio of two groups at 6 months follow-up

  2. Central retinal thickness changes [6 months]

    Comparing the central retinal thickness changes of two groups at 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Beijing Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yu Xiaobing, Prof., Beijing Hospital
ClinicalTrials.gov Identifier:
NCT05687422
Other Study ID Numbers:
  • 2021-I2M-C&T-B-093
First Posted:
Jan 18, 2023
Last Update Posted:
Jan 18, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Central Serous Chorioretinopathy

Study Results

No Results Posted as of Jan 18, 2023