577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy

NCT ID: NCT02587767

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-12-31

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.

Detailed Description

Central serous chorioretinopathy(CSC) is characterized by serous detachment of neurosensory retina which can cause lose in visual acuity.Some studies have shown that Half-dose photodynamic therapy(PDT) is effective on CSC,although accompanied with side-effects,such as choroidal ischemia, retinal pigmental epithelium(RPE) atrophy,and RPE rip,and with exorbitant price.Recent retrospective studies suggest micropulse laser (MPL) therapy may also be effective without obvious complications in this disease. But to date, there is no study on effectiveness of CSC between PDT and MPL.

The study is the first prospective randomized controlled trial about 577nm micropulse laser versus half-dose photodynamic therapy on acute central serous chorioretinopathy.The null hypothesis of the study is that there is difference between MPL and half-dose photodynamic therapy on acute central serous chorioretinopathy at first month after treatment.The primary outcome measures is the proportion of eyes with complete absorption of subretinal fluid at 1 month after treatment.

Conditions

Acute Central Serous Chorioretinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

577-MPL

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.

Group Type: EXPERIMENTAL

577-MPL

Intervention Type: DEVICE

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.

HD-PDT

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.

Group Type: ACTIVE_COMPARATOR

HD-PDT

Intervention Type: DEVICE

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.

Interventions

577-MPL

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.

Intervention Type: DEVICE

HD-PDT

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. onset for the first time, as an episode duration of less than 6 months

2. patient was between 18 and 55 years of age

3. the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT)

4. active fluorescein leakage during fluorescein angiography (FA)

5. best corrected visual acuity (BCVA) more than 0.1, and less than 1.0

Exclusion Criteria

1. previous PDT, focal photocoagulation, intravitreal injections of anti-vascular endothelial growth factor, or ocular surgery

2. other macular abnormalities such as choroidal neovascularization(CNV) or polypoidal choroidal vasculopathy(PCV)

3. retinal atrophy

4. pregnancy

5. inability to obtain photographs or to perform FA

6. use of steroid systemically or topically in the last 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jin Chen-jin

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chenjin Jin

Role: STUDY_DIRECTOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Lijun Zhou

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

577MPLACS(Marshall Study)

Identifier Type: -

Identifier Source: org_study_id