Evaluation of Morphological and Functional Changes in Eyes With Epiretinal Membrane After Vitrectomy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in BCVA from 1 month post-PPV (pre-laser) to 4 months post-PPV.
研究概览
简要总结
The goal of this interventional study is to assess the dynamics of structural and functional retinal changes in eyes with epiretinal membrane (ERM) after pars plana vitrectomy (PPV). Other study objectives include:
- Identification of preoperative prognostic factors associated with better postoperative outcomes.
- Evaluation of the utility of advanced, highly specialized retinal function testing as diagnostic-prognostic tools in patients after ERM surgery.
- Definition of updated qualification criteria and surgical indications for vitrectomy in patients with ERM.
Researchers will compare a laser-treated group (additional subthreshold micropulse yellow laser (577 nm) at 1 month post-PPV) with a nonlaser group (no additional laser) to see whether early postoperative subtreshold micropulse laser therapy (SMLT) affects selected functional and morphometric retinal parameters after ERM peeling.
This prospective, randomized, controlled, single-center study includes 100 pseudophakic patients scheduled for surgical ERM removal.
Eligibility requires a visually significant ERM with metamorphopsia and/or reduced best-corrected visual acuity.
Participants are classified preoperatively by OCT-based Govetto staging and randomized 1:1 to either the laser-treated group or the non-laser (control) group. All patients undergo standard 25-gauge PPV with ERM peeling, followed by ILM peeling and SF₆ gas tamponade, performed by a single experienced vitreoretinal surgeon.
Follow-up visits occur preoperatively, and at 1 and 4 months postoperatively; SMLT is performed at 1 month in the laser arm. Baseline questionnaire captures metamorphopsia presence (yes/no) and duration (<6, 6-12, >12 months).
Assessments include:
- best corrected visual acuity (BCVA) [Snellen and ETDRS charts]
- enhanced depth imaging optical coherence tomography (EDI-OCT) [retinal thickness in the nine Early Treatment Diabetic Retinopathy Study (ETDRS) subfields (μm); total retinal volume (mm³); subfoveal choroidal thickness (μm); choroidal area (mm²)]
- OCT angiography (OCTA) [foveal avascular zone (FAZ) area in both the superficial (SVC) and deep vascular complexes (DVC) (mm²)]
- multifocal electroretinography (mfERG) [P1-wave retinal response density (nV/deg²) in rings R1-R6; P1-wave implicit (peak) time in rings R1-R6 (ms)]
- microperimetry (average threshold (dB); fixation stability P1/P2; fixation variability via 63% and 95% bivariate contour ellipse area (BCEA)]
- wide-field fundus imaging
Statistical analyses will be performed at a significance level of p<0.05, using appropriate parametric or nonparametric methods selected based on data distribution and measurement scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Epiretinal membrane (ERM) - either associated with metamorphopsia or causing a marked reduction in best corrected visual acuity
- •Pseudophakia
排除标准
- •Coexisting ocular or retinal diseases other than ERM
- •Evidence of ocular inflammation or any active intraocular inflammatory process
研究组 & 干预措施
Laser-treated group
Additional subthreshold micropulse laser therapy (SMLT) using a 577 nm solid-state yellow diode laser, applied to the macular area (thirty 5 × 5 spot sizes of 160 µm, zero-spot spacing, including the fovea; fixed power 250 mW; exposure 200 ms; micropulse mode, 5% duty cycle) performed 1 month after pars plana vitrectomy (PPV).
干预措施: Subtreshold micropulse laser therapy (Device)
Laser-treated group
Additional subthreshold micropulse laser therapy (SMLT) using a 577 nm solid-state yellow diode laser, applied to the macular area (thirty 5 × 5 spot sizes of 160 µm, zero-spot spacing, including the fovea; fixed power 250 mW; exposure 200 ms; micropulse mode, 5% duty cycle) performed 1 month after pars plana vitrectomy (PPV).
干预措施: Pars plana vitrectomy (Procedure)
Nonlaser group
Pars plana vitrectomy (PPV) performed without subsequent subthreshold micropulse laser therapy (SMLT).
干预措施: Pars plana vitrectomy (Procedure)
结局指标
主要结局
Change in BCVA from 1 month post-PPV (pre-laser) to 4 months post-PPV.
时间窗: 1 month (pre-laser) and 4 months postoperatively.
Between-group difference (laser-treated group vs nonlaser group) in change in best corrected visual acuity (BCVA) from Month 1 to Month 4. BCVA measured using Snellen and ETDRS charts.
次要结局
- Change in fixation stability P1 and P2 on microperymetry.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in mfERG P1-wave retinal response density in rings R1-R6.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in mfERG P1-wave implicit time in rings R1-R6.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in average threshold on microperymetry.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in fixation stability P1 and P2 on microperymetry.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in fixation variability on microperymetry.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in retinal thickness on EDI-OCT.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in total retinal volume on EDI-OCT.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in subfoveal choroidal thickness on EDI-OCT.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in choroidal area on EDI-OCT.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in FAZ area in the SVC and DVC on OCTA.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in retinal thickness on EDI-OCT.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in total retinal volume on EDI-OCT.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in subfoveal choroidal thickness on EDI-OCT.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in choroidal area on EDI-OCT.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in FAZ area in the SVC and DVC on OCTA.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in mfERG P1-wave retinal response density in rings R1-R6.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in mfERG P1-wave implicit time in rings R1-R6.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in average threshold on microperymetry.(Baseline (pre-op), 1 month, and 4 months post-op.)
- Change in fixation variability on microperymetry.(Baseline (pre-op), 1 month, and 4 months post-op.)