Long-Term Clinical Results of Ab-Interno Trabeculotomy in Glaucoma Management
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.
調査の概要
詳細な説明
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)
All examinations are non-invasive, painless, and consistent with routine ophthalmic care. No additional follow-up visits are required beyond this single study contact.
Pre-operative data, including baseline IOP, glaucoma diagnosis, medication use, and surgical details are obtained from existing medical records. These are compared with findings at the study visit to evaluate long-term treatment success.
The study is initiated and funded by the Department of Ophthalmology, University Hospital Würzburg. No external funding or industry sponsorship is involved. The study has been approved by the responsible Ethics Committee with no objections raised.
Approximately 180 participants are planned for enrollment. Data are pseudonymized and stored on password-protected servers. No data transfer to third parties or outside the European Union is performed. Data will be deleted no later than 10 years after study completion.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Raoul Verma-Führing, Dr.
- 電話番号：+49 931 20120458
- メール：augenklinik@ukw.de
研究連絡先のバックアップ
- 名前：Eric Schreiner
- メール：ericschreiner03studium@gmail.com
研究場所
-
-
Bavaria
-
Würzburg、Bavaria、ドイツ、97080
- 募集
- University Hospital Würzburg
-
コンタクト：
- Raoul Verma-Führing
- 電話番号：+49 931 20120351
- メール：augenklinik@ukw.de
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inability to attend the study visit
- Withdrawal of informed consent
- Insufficient medical records for pre-operative baseline data retrieval
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
AIT Cohort
Tha AIT cohort consists of glaucoma patients who previously underwent ab-interno trabeculotomy (AIT) using the Trabectome device at the Department of Ophthalmology, University Hospital Würzburg.
Participants are invited for a single follow-up visit to assess long-term intraocular pressure control, visual acuity, optic nerve status (OCT), and visual field outcomes compared to pre-operative baseline data obtained from medical records.
|
Ab-interno trabeculotomy (AIT) is a minimally invasive glaucoma surgery (MIGS) performed using the Trabectome device.
The procedure ablates the trabecular meshwork and the inner wall of Schlemm's canal via an ab-interno approach, thereby reducing resistance to aqueous humor outflow and lowering intraocular pressure.
The surgery is performed under local or general anesthesia and can be combined with cataract surgery.
In this observational study, the intervention was performed prior to study enrollment; no surgical intervention is performed as part of the study itself.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Intraocular Pressure (IOP) from Pre-operative Baseline to Follow-up
時間枠：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.
|
From pre-operative baseline to single follow-up visit (minimum 4 years, up to 10 years post-surgery)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Number of Intraocular Pressure-Lowering Medications from Pre-operative Baseline to Follow-up
時間枠：From pre-operative baseline to single follow-up visit (minimum 4 years, up to 10 years post-surgery)
|
Total number of topical and systemic anti-glaucomatous medications used by the patient at the time of the study visit, compared to the number documented in medical records prior to surgery.
Reduction in medication burden is considered an additional indicator of surgical success.
|
From pre-operative baseline to single follow-up visit (minimum 4 years, up to 10 years post-surgery)
|
|
Visual Acuity at Follow-up
時間枠：At single follow-up visit (minimum 4 years, up to 10 years post-surgery)
|
Visual acuity assessed using standardized visual acuity charts at the study visit.
Results are recorded in decimal notation and converted to logMAR for analysis.
Pre-operative VA is obtained from medical records for comparison.
|
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)
時間枠：At single follow-up visit (minimum 4 years, up to 10 years post-surgery)
|
Peripapillary RNFL thickness (µm) assessed by spectral- domain optical coherence tomography (SD-OCT) at the study visit.
Global and sectoral RNFL values are recorded.
Results are compared to pre-operative OCT data from medical records where available, to evaluate structural progression of glaucomatous optic neuropathy.
|
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
時間枠：From date of surgery to single follow-up visit (minimum 4 years, up to 10 years post-surgery)
|
Proportion of patients who required additional surgical or laser intervention (e.g., trabeculectomy, tube shunt implantation, selective laser trabeculoplasty) due to insufficient IOP control following AIT.
Data obtained retrospectively from medical records.
Surgical failure is defined as the need for re-intervention at any time point after the primary procedure.
|
From date of surgery to single follow-up visit (minimum 4 years, up to 10 years post-surgery)
|
協力者と研究者
捜査官
- 主任研究者：Raoul Verma-Führing, Dr.、Wuerzburg University Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。