Dataset Information

Efficacy and safety of subthreshold micropulse laser compared with threshold conventional laser in central serous chorioretinopathy.

ABSTRACT:

Purpose

To compare the efficacy and safety of subthreshold micropulse laser (SML) with threshold conventional laser (TCL) in central serous chorioretinopathy (CSC).

Methods

Prospective, randomized, double-masked, non-inferiority, 12-week clinical trial. Patients were randomly assigned 1:1 to SML group or TCL group. Patients in the SML group were treated with 577?nm micropulse laser. The spot size was 160?µm, the duty cycle was 5% and exposure time was 0.2?s. The power was 50% threshold tested. Patients in the TCL group were treated with 577?nm continuous laser. The power was 100% threshold tested. The primary outcome was the mean change in best-corrected visual acuity (BCVA) at week 12, with a non-inferiority limit of five letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts.

Results

Eighty-eight patients were enroled. Seventy-seven patients were male. Forty-four patients were in SML group and 44 in TCL group. At week 12, SML was equivalent to TCL with a gain of 6.23?±?8.59 and 6.61?±?6.35 letters, respectively, (SML-TCL difference: -0.38 letters; 95% confidence interval (CI):-3.58-2.81; P_{non-inferiority}?=?0.0026). There was no statistically significant difference between the two groups (t?=?0.240, P?=?0.811). At week 12, the proportion of patients whose SRF had been totally absorbed was 63.63 and 81.82% respectively for SML and TCL groups. There was no statistically significant difference between the two groups (?²?=?3.67, P?=?0.056).

Conclusions

Both SML and TCL can improve visual acuity in CSC. SML was non-inferior to TCL in the improvement of BCVA.

SUBMITTER: Sun Z

PROVIDER: S-EPMC7608089 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of subthreshold micropulse laser compared with threshold conventional laser in central serous chorioretinopathy.

Sun Zuhua Z Huang Ying Y Nie Chaochao C Wang Zhijie Z Pei Junqing J Lin Bing B Zhou Rong R Zhang Junyan J Chong Victor V Liu Xiaoling X

Eye (London, England) 20191129 9

<h4>Purpose</h4>To compare the efficacy and safety of subthreshold micropulse laser (SML) with threshold conventional laser (TCL) in central serous chorioretinopathy (CSC).<h4>Methods</h4>Prospective, randomized, double-masked, non-inferiority, 12-week clinical trial. Patients were randomly assigned 1:1 to SML group or TCL group. Patients in the SML group were treated with 577 nm micropulse laser. The spot size was 160 µm, the duty cycle was 5% and exposure time was 0.2 s. The power was 50% thre ...[more]

PMID: 31784704

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Project description:Chronic central serous chorioretinopathy (cCSC) is an eye disease characterized by an accumulation of serous fluid under the retina. It is postulated that this fluid accumulation results from hyperpermeability and swelling of the choroid, the underlying vascular tissue of the eye, causing a dysfunction of the retinal pigment epithelium. This fluid accumulation causes neuroretinal detachment. A prolonged neuroretinal detachment in the macula can lead to permanent vision loss. Therefore, treatment is aimed primarily at achieving resolution of subretinal fluid, preferably within the first 4 months after diagnosis of the disease. A broad spectrum of treatment modalities has been investigated in cCSC, but no consensus exists on the optimal treatment of cCSC. Currently, photodynamic therapy (PDT) and high-density subthreshold micropulse laser treatment (HSML) are among the most frequently cited treatments in obtaining successful neuroretinal reattachment.This is a randomized, controlled, open-label, multicenter trial comparing the efficacy of half-dose PDT to HSML in treating patients with cCSC. A total of 156 patients will be recruited, 78 patients in each treatment arm, with a maximum follow-up duration of 8 months after the first treatment. A complete ophthalmological examination with vision-related quality of life (NEI VFQ-25) and stress questionnaires, will be performed at baseline, 6 to 8 weeks after the first treatment, 6 to 8 weeks after a second treatment (if necessary), and at the final follow-up visit at 7 to 8 months after the first treatment. Treatment visits will be scheduled within 3 weeks after the baseline visit, and within 3 weeks after the first control visit, if a second treatment is required.Both half-dose PDT and HSML may be effective treatments in cCSC, but because of the lack of prospective randomized controlled trials, which treatment should be the first choice remains unclear. The aim of this study is to compare the efficacy of half-dose PDT to HSML. The primary endpoint to evaluate efficacy will be a complete absence of subretinal fluid on optical coherence tomography after treatment. Secondary functional endpoints include change in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity, retinal sensitivity on microperimetry, and NEI VFQ-25 questionnaire of visual functioning. Registration number Institutional Review Board (CMO Arnhem-Nijmegen, the Netherlands): 2013/203 NL nr.: 41266.091.13 TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01797861 . Date of registration: 21 February 2013.

Project description:PurposeTo assess the safety and efficacy of selective retina therapy (SRT) using a Q-switched neodymium-doped yttrium lithium fluoride laser with feedback systems in patients with idiopathic central serous chorioretinopathy (CSC).MethodsThis randomized clinical trial enrolled patients having at least 3-month symptom of CSC. From month 3 visit, all subjects in both groups were eligible for SRT retreatment if they showed persistent or recurrent subretinal fluid (SRF). The primary outcome was complete resolution of SRF by optical coherence tomography at 3 months after treatment. The secondary outcomes were changes in SRF, central macular thickness (CMT) and best-corrected visual acuity at the 1-, 3-, and 6-month examinations.ResultsSixty-eight CSC patients were included (SRT, 31; control, 37). After 1 and 3 months, complete resolution of SRF was achieved in 25.8% and 54.8% of SRT group and 17.6% and 35.1% of controls. The differences were not statistically significant (p = 0.424 and p = 0.142, respectively). However, mixed model for repeated measures analyses showed that the reduction of SRF and CMT were observed earlier in SRT group than in the sham group (least squares mean difference, -59.7 µm; 95% confidence interval, -98.2 to -21.2; p = 0.0029; least squares mean difference -67.0 µm; 95% confidence interval, -104.8 to -29.2; p = 0.0007, respectively). Significant reduction of SRF (≥50% reduction from baseline) was more frequently observed in SRT group (80.6%) than the sham group (44.1%) at month 1 (p = 0.007). Early reduction of SRF and CMT was more abundant in SRT group with symptom duration less than 6 months. Treatment related serious adverse events were not observed.ConclusionsSRT using a Q-switched neodymium-doped yttrium lithium fluoride laser with feedback system was safe in this trial and effective for early resolution of SRF in the CSC patients. Early intervention with SRT can be a safe alternative for patients with acute symptomatic CSC.

Dataset Information

Efficacy and safety of subthreshold micropulse laser compared with threshold conventional laser in central serous chorioretinopathy.

Purpose

Methods

Results

Conclusions

Publications

Efficacy and safety of subthreshold micropulse laser compared with threshold conventional laser in central serous chorioretinopathy.

Similar Datasets

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