NCT02587767

Brief Summary

The purpose of this study is to determine whether micropulse laser (MPL) is different to half-dose photodynamic therapy on acute central serous chorioretinopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

3.2 years

First QC Date

October 17, 2015

Last Update Submit

April 4, 2022

Conditions

Acute Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (1)

  • the proportion of eyes with complete absorption of subretinal fluid(SRF)

    The primary outcome measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images

    1 month

Secondary Outcomes (4)

  • Change of Best Corrected Visual Acuity(BCVA)

    1 month, 3 month, 6 month

  • Change of fundus autofluorescence

    1 month, 3 month, 6 month

  • Change in 10°retinal sensitivity

    1 month, 3 month, 6 month

  • the proportion of eyes with complete absorption of subretinal fluid(SRF)

    6 month

Study Arms (2)

577-MPL

EXPERIMENTAL

577nm micropulse laser(577-MPL) will be performed of the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein.Multiple laser spots will be applied, covering the leakage area.

Device: 577-MPL

HD-PDT

ACTIVE COMPARATOR

Half-dose photodynamic therapy (HD-PDT) is administered to the patients. At 15 minutes after the start of the infusion, PDT laser treatment is performed with standard 50 J/cm2 fluency, a wavelength of 689nm, and a treatment duration of 83 seconds.

Device: HD-PDT

Interventions

577-MPLDEVICE

All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm LaserSystem) in 577-MPL arm. The individual power for the patient was titrated at a normal area of near the affected area in micropulse model.The power titration was started at 700 milliwatt(mW) and then gradually increased until a just visible burn was seen. When this threshold was reached, the power was reduced by 50%, using a 100-μm spot diameter and a 200-ms duration with 5 % duty cycle.

577-MPL
HD-PDTDEVICE

5 minutes after the start of the half-dose verteporfin infusion, the PDT treatment will been performed in HD-PDT arm. The treatment is performed with standard fluency (50 J/cm2), a PDT laser wavelength of 689 nm, and a standard treatment duration of 83 seconds.

HD-PDT

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • onset for the first time, as an episode duration of less than 6 months
  • patient was between 18 and 55 years of age
  • the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT)
  • active fluorescein leakage during fluorescein angiography (FA)
  • best corrected visual acuity (BCVA) more than 0.1, and less than 1.0

You may not qualify if:

  • previous PDT, focal photocoagulation, intravitreal injections of anti-vascular endothelial growth factor, or ocular surgery
  • other macular abnormalities such as choroidal neovascularization(CNV) or polypoidal choroidal vasculopathy(PCV)
  • retinal atrophy
  • pregnancy
  • inability to obtain photographs or to perform FA
  • use of steroid systemically or topically in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Study Officials

  • Chenjin Jin

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY DIRECTOR

  • Lijun Zhou

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 17, 2015

First Posted

October 27, 2015

Study Start

September 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 5, 2022

Record last verified: 2022-04

Locations

CN(1)