Targeted subthreshold micropulse laser (SMPL) versus non-targeted pattern (NTP) laser in chronic central serous chorioretinopathy (ViiV study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 148
- 试验地点
- 1
研究概览
简要总结
All eligible subjects with non-resolving fluid in chronic CSC will be randomised into one of the arms. A single episode of laser will be delivered on a diode laser platform. The fluid resolution will be assessed in two follow-up visits at 6-week intervals.
The screening period (Visit 1) may last up to 14 days, during which, after signing the Informed consent, several procedures will be performed to assess eligibility (patient and study eye). For study eye eligibility, refraction, axial length, BCVA, intraocular pressure, anterior biomicroscopy and ophthalmoscopy will be performed; also OCT, FA, AF, OCTA and ICGA images will be taken. For patient eligibility medical history and concomitant medication information will be completed.
At Visit 2 (Day 1) if eligibility criteria are met, (Visit 1 and Visit 2 can be performed on the same day) patients will be randomised into two treatment groups (ratio 1:1). The randomised subjects (Group I - NTP) and Group II - SMPL) will receive the study intervention by the investigator.
Patients will return (Visit 3) to the clinical center at 6 weeks (Day 42 ± 7 days) and 12 weeks (Day 84 ± 7 days) to undergo efficacy assessments and imaging. At each visit, patients will be examined by the evaluating investigator, consisting of visual acuity measurements, ophthalmic examinations and evaluation of adverse events like worsening CSC and visual field defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults of both genders aged 30 to 60 years of both gender.
- •2.Diagnosis of cCSC confirmed at screening visit by complete ocular examination and multimodal imaging in the study eye using the following criteria.
- ••Non resolving and recurrent CSC represented by subretinal fluid (SRF) involving the macular center with or without the presence of pigment epithelial detachment (PED).
- ••A known history of waxing and waning CSC of more than 6 months.
- ••Non resolving and recurrent CSC with at least a single, multifocal, diffuse or poorly defined leak on fluorescein angiography (FA).
- •Presence of window defects on FA.
- ••Sub-foveal choroidal thickness (SFCT) of greater than equal to 300microns, defined as the distance from the RPE line to the hyperreflective line behind the large vessel layers of the choroid, presumed to be the choroid and sclera interface, manually measured in the horizontal section, passing directly through the fovea.
- •3.Best corrected vision score of 73 to 19 at test distance of 4 meters on ETDRS chart at recruitment (Snellen equivalent 20 by 40 to 20 by 400) 4.Decrease in vision primarily secondary to cCSC 5.Willing to sign an informed consent form before initiation of any study related procedure.
排除标准
- •1.Patients not able to comply with the study or follow-up procedures 2.Laser/ PDT treatment for CSC within 3 months of enrolment 3.Use of corticosteroids in all forms within 3 months of enrolment 4.Pharmacological treatment (eplerenone) for CSC within a month of enrolment 5.Eyes with choroidal neovascularization demonstrable on multimodal imaging (OCTA/FA/ICGA) 6.Presence of intraretinal fluid (IRF), intraretinal cysts (IRC), and retinal schisis.
- •7.Non-study eye vision of less than 20/200, 8.Aphakia in study eye 9.History of glaucoma in either eye (IOP greater than 24 mmHg) 10.Cataract grade that may affect retinal imaging 11.History of hypersensitivity to fluorescein dye 12.Presence of sub-retinal fluid (SRF) or intra-retinal fluid (IRF) secondary to causes other than CSC 13.Presence of active infectious disease or intra-ocular inflammation, active or suspected periocular infection in either eye at the time of enrolment 14.History of intra-ocular surgery within 3 months in the study eye before the randomization 15.Pregnancy induced CSC.
- •16.Any advanced, severe or unstable disease or its treatment at the time of enrolment that could interfere with primary and secondary outcome evaluations, including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at unique risk.
- •17.Ocular disorders in the study eye at the time of enrolment that may confound the interpretation of study results, compromise visual acuity, or require medical or surgical intervention during the 3-month study period (including retinal detachment, cataract and pre-retinal membrane of the macula).
研究者
Dr Umesh Chandra Behera
L V Prasad Eye Institute