- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07713056
Clinical Characteristics of Pigmentary Glaucoma and Efficacy Analysis of Ab-interno 120° Trabeculotomy
17 juli 2026 uppdaterad av: Zhongnan Hospital
Clinical Characteristics of Pigmentary Glaucoma and Efficacy Analysis of Ab-interno 120° Trabeculotomy: A Case Series Study
This study aims to investigate the clinical characteristics of pigmentary glaucoma and evaluate the efficacy and safety of ab-interno 120° trabeculotomy during the 6-month postoperative follow-up period.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a single-center, retrospective case series study.
Patients with pigmentary glaucoma treated at Zhongnan Hospital of Wuhan University will be enrolled.
By systematically collecting their baseline demographic characteristics, ocular examination results, and prior treatment history, the study aims to summarize the distribution pattern of clinical features of pigmentary glaucoma.
With the 6-month postoperative follow-up as the primary endpoint, the study will evaluate the intraocular pressure-lowering effect of ab-interno 120° trabeculotomy, changes in medication dependence, and the stability of visual field and retinal nerve fiber layer, while observing the occurrence of related intraoperative and postoperative complications, so as to provide clinical evidence for individualized surgical treatment of pigmentary glaucoma.
Studietyp
Observationell
Inskrivning (Beräknad)
11
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Min Ke, doctor
- Telefonnummer: 18672395959
- E-post: Keminyk@163.com
Studera Kontakt Backup
- Namn: Xiaomin Chen, doctor
- Telefonnummer: 13657237773
- E-post: xminchen@whu.edu.cn
Studieorter
-
-
Hubei
-
Wuhan, Hubei, Kina, 430071
- Rekrytering
- Zhongnan Hospital of Wuhan University
-
Kontakt:
- Min Ke, Doctor
- Telefonnummer: +86-18672395959
- E-post: keminyk@163.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
This study included patients with pigmentary glaucoma who underwent primary isolated ab-interno 120° trabeculotomy at Zhongnan Hospital of Wuhan University.
All patients had complete baseline data (including intraocular pressure, visual field, and OCT retinal nerve fiber layer measurements) and at least 6 months of follow-up data.
Patients with other types of glaucoma, prior ocular trauma or surgery history, combined intraoperative procedures, severe systemic diseases, or incomplete key data were excluded.
Beskrivning
Inclusion Criteria:
- Meet the clinical diagnostic criteria for pigmentary glaucoma, with typical signs of pigment dispersion syndrome, extensive trabecular meshwork pigmentation, pathological intraocular pressure elevation, glaucomatous optic nerve damage, and characteristic visual field defects;
- Underwent primary isolated ab-interno 120° trabeculotomy as the initial surgical treatment;
- Have complete preoperative and postoperative examination data, including slit-lamp biomicroscopy, gonioscopy, intraocular pressure, visual field, and OCT RNFL measurements;
- Able to complete regular follow-up for at least 6 months postoperatively.
Exclusion Criteria:
- Patients with exfoliation syndrome, exfoliative glaucoma, or other types of primary or secondary glaucoma;
- Patients with a history of ocular trauma, intraocular surgery, uveitis, severe retinopathy, or other ocular diseases affecting intraocular pressure and visual function assessment;
- Patients who underwent combined procedures such as concurrent cataract surgery or other anti-glaucoma surgeries during the operation;
- Patients with severe systemic diseases, cognitive or psychiatric disorders that prevent cooperation with examinations and follow-up;
- Patients with missing key clinical or follow-up data that preclude efficacy and prognosis evaluation.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Intraocular Pressure (IOP) at 6 Months Postoperatively
Tidsram: 6 months postoperatively
|
Change in intraocular pressure from baseline to 6 months after ab-interno 120° trabeculotomy, including the mean IOP level, absolute reduction, and percentage reduction relative to baseline.
|
6 months postoperatively
|
|
Change in the Number of Intraocular Pressure-Lowering Medications at 6 Months
Tidsram: 6 months postoperatively
|
Change in the number of glaucoma medications used by patients, comparing baseline to 6 months after surgery.
|
6 months postoperatively
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in Visual Field Parameters at 6 Months Postoperatively
Tidsram: 6 months postoperatively
|
Changes in visual field mean deviation (MD) from baseline to 6 months postoperatively.
|
6 months postoperatively
|
|
Changes in Visual Field Parameters at 6 Months Postoperatively
Tidsram: 6 months postoperatively
|
Changes in pattern standard deviation (PSD) from baseline to 6 months postoperatively.
|
6 months postoperatively
|
|
Changes in Visual Acuity at 6 Months Postoperatively
Tidsram: 6 months postoperatively
|
Changes in best-corrected visual acuity (BCVA) from baseline to 6 months postoperatively.
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6 months postoperatively
|
|
Status of Trabeculotomy Site on Gonioscopy
Tidsram: 6 months postoperatively
|
Patency and morphological status of the trabecular meshwork incision site as assessed by gonioscopy at 6 months postoperatively.
|
6 months postoperatively
|
|
Improvement in Pupillary Block and Iris Configuration
Tidsram: 6 months postoperatively
|
Improvement in pupillary block and iris configuration as assessed by anterior segment optical coherence tomography (OCT) at 6 months postoperatively.
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6 months postoperatively
|
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Rate of Secondary Glaucoma Surgery
Tidsram: From the day of surgery to 6 months postoperatively
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Proportion of patients who require additional glaucoma surgery during the 6-month follow-up period.
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From the day of surgery to 6 months postoperatively
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Wen Zeng, doctor, Zhongnan Hospital
- Huvudutredare: Nan Zhang, doctor, Zhongnan Hospital
- Huvudutredare: Xuetian Yu, The Second Clinical College of Wuhan University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2026
Primärt slutförande (Beräknad)
30 september 2026
Avslutad studie (Beräknad)
30 september 2026
Studieregistreringsdatum
Först inskickad
13 juli 2026
Först inskickad som uppfyllde QC-kriterierna
17 juli 2026
Första postat (Faktisk)
20 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20260523
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