NCT05687422

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

December 25, 2022

Last Update Submit

January 13, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Subretinal fluid regression ratio

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

    6 months

  • Central retinal thickness changes

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

    6 months

Study Arms (2)

100μm laser spot diameter group

EXPERIMENTAL
Procedure: 100μm laser spot diameter micropulse laser

200μm laser spot diameter group

ACTIVE COMPARATOR
Procedure: 200μm laser spot diameter micropulse laser

Interventions

100μm laser spot diameter micropulse laser at baseline, then follow-up for 6 months

100μm laser spot diameter group

200μm laser spot diameter micropulse laser at baseline, then follow-up for 6 months

200μm laser spot diameter group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zhang Y, Wang J, Liu J, Gu X, Song S, Yu X. Three-dimensional choroidal characteristics in different subtypes of central serous chorioretinopathy using swept-source optical coherence tomography angiography. Graefes Arch Clin Exp Ophthalmol. 2025 Mar;263(3):689-697. doi: 10.1007/s00417-024-06691-8. Epub 2024 Nov 19.

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

December 25, 2022

First Posted

January 18, 2023

Study Start

February 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 18, 2023

Record last verified: 2023-01