Long-Term Clinical Results of Ab-Interno Trabeculotomy in Glaucoma Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Intraocular Pressure (IOP) from Pre-operative Baseline to Follow-up
研究概览
简要总结
Glaucoma is one of the leading causes of irreversible vision loss worldwide. Elevated intraocular pressure (IOP) is the most important risk factor for the development and progression of the disease.
Ab-interno trabeculotomy (AIT) using the Trabectome system is a minimally invasive glaucoma surgery (MIGS) that reduces aqueous humor outflow resistance by ablating the trabecular meshwork and the inner wall of Schlemm's canal, thereby lowering intraocular pressure.
Previous studies have demonstrated good short-term efficacy of this procedure. However, robust long-term data spanning several years remain scarce.
The aim of this study is to evaluate the long-term outcomes of AIT in glaucoma patients who underwent surgery between 2019 and 2021 at the Department of Ophthalmology, University Hospital Würzburg. Patients are invited for a single study visit at which intraocular pressure, visual acuity, anterior chamber angle by gonioscopy, and optic nerve structure by optical coherence tomography (OCT) are assessed. The collected data are compared with pre-operative baseline values obtained from medical records.
The results are intended to improve the assessment of long-term surgical success and to optimize patient selection for this procedure in the future.
详细描述
Glaucoma is a progressive optic neuropathy in which elevated intraocular pressure (IOP) represents the primary modifiable risk factor. Ab-interno trabeculotomy (AIT) with the Trabectome is a minimally invasive glaucoma surgery (MIGS) that reduces IOP by ablating the trabecular meshwork and inner wall of Schlemm's canal, thereby improving aqueous humor outflow.
Previous studies have demonstrated favorable short-term IOP reduction and a good safety profile. However, robust long-term data evaluating sustained surgical success, disease progression, and the need for additional interventions over multiple years are currently lacking.
This single-center, observational study with a retrospective pre-operative baseline and a prospective cross-sectional follow-up visit addresses this knowledge gap. Patients who underwent AIT at the Department of Ophthalmology, University Hospital Würzburg, are contacted and invited for a single study visit of approximately 30 minutes.
At this visit, the following assessments are performed:
- Medical history review since the time of surgery
- Visual acuity assessment
- Goldmann applanation tonometry (IOP measurement)
- Slit-lamp biomicroscopy including gonioscopy for the anterior chamber angle
- Optical coherence tomography (OCT) of the optic nerve head and retinal nerve fiber layer (RNFL)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of glaucoma
- •Previous ab-interno trabeculotomy (AIT) using the Trabectome device performed at the Department of Ophthalmology, University Hospital Würzburg
- •Surgery performed between 2019 and 2021
- •Ability to provide written informed consent
- •Age ≥ 18 years at time of surgery
排除标准
- •Inability to attend the study visit
- •Withdrawal of informed consent
- •Insufficient medical records for pre-operative baseline data retrieval
结局指标
主要结局
Change in Intraocular Pressure (IOP) from Pre-operative Baseline to Follow-up
时间窗: From pre-operative baseline to single follow-up visit (minimum 4 year, up to 10 years post-surgery)
Mean intraocular pressure (mmHg) measured by Goldmann applanation tonometry at the study visit, compared to pre-operative baseline IOP obtained from medical records. Surgical success is defined as IOP reduction of ≥20% from baseline and/or IOP ≤18 mmHg, with or without anti-glaucomatous medication.
Change in Intraocular Pressure (IOP) from Pre-operative Baseline to Follow-up
时间窗: From pre-operative baseline to single follow-up visit (minimum 4 years, up to 10 years post-surgery)
Mean intraocular pressure (mmHg) measured by Goldmann applanation tonometry at the study visit, compared to pre-operative baseline IOP obtained from medical records. Surgical success is defined as IOP reduction of ≥20% from baseline and/or IOP ≤18 mmHg, with or without anti-glaucomatous medication.
次要结局
- Change in Number of Intraocular Pressure-Lowering Medications from Pre-operative Baseline to Follow-up(From pre-operative baseline to single follow-up visit (minimum 4 year, up to 10 years post-surgery))
- Visual Acuity at Follow-up(At single follow-up visit (minimum 4 year, up to 10 years post-surgery))
- Peripapillary Retinal Nerve Fiber Layer (RNFL) Thickness as Measured by Optical Coherence Tomography (OCT)(At single follow-up visit (minimum 4 year, up to 10 years post-surgery))
- Rate of Surgical Failure Requiring Additional IOP-Lowering Intervention After Ab-Interno Trabeculotomy(From date of surgery to single follow-up visit (minimum 4 year, up to 10 years post-surgery))
- Change in Number of Intraocular Pressure-Lowering Medications from Pre-operative Baseline to Follow-up(From pre-operative baseline to single follow-up visit (minimum 4 years, up to 10 years post-surgery))
- Visual Acuity at Follow-up(At single follow-up visit (minimum 4 years, up to 10 years post-surgery))
- Peripapillary Retinal Nerve Fiber Layer (RNFL) Thickness as Measured by Optical Coherence Tomography (OCT)(At single follow-up visit (minimum 4 years, up to 10 years post-surgery))
- Rate of Surgical Failure Requiring Additional IOP-Lowering Intervention After Ab-Interno Trabeculotomy(From date of surgery to single follow-up visit (minimum 4 years, up to 10 years post-surgery))
研究者
Raoul Verma-Führing
Principal Investigator
Wuerzburg University Hospital