Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
Location status: Recruiting
NCT Number: NCT07713056
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.
Interested in participating?
Request Info16 year–80 year
All sexes
Observational
Wuhan, Hubei, 430071, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A minimally invasive glaucoma surgery (MIGS) procedure performed via an ab interno approach, involving a 120-degree incision of the trabecular meshwork to improve aqueous humor outflow.
Time frame: 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.
Time frame: 6 months postoperatively
Change in the number of glaucoma medications used by patients, comparing baseline to 6 months after surgery.
Time frame: 6 months postoperatively
Changes in visual field mean deviation (MD) from baseline to 6 months postoperatively.
Time frame: 6 months postoperatively
Changes in pattern standard deviation (PSD) from baseline to 6 months postoperatively.
Time frame: 6 months postoperatively
Changes in best-corrected visual acuity (BCVA) from baseline to 6 months postoperatively.
Time frame: 6 months postoperatively
Patency and morphological status of the trabecular meshwork incision site as assessed by gonioscopy at 6 months postoperatively.
Time frame: 6 months postoperatively
Improvement in pupillary block and iris configuration as assessed by anterior segment optical coherence tomography (OCT) at 6 months postoperatively.
Time frame: From the day of surgery to 6 months postoperatively
Proportion of patients who require additional glaucoma surgery during the 6-month follow-up period.
Contact information is provided by the study sponsor or research team.
Min Ke, doctor
CONTACT
Xiaomin Chen, doctor
CONTACT
Zhongnan Hospital
Other
Clinical Characteristics of Pigmentary Glaucoma and Efficacy Analysis of Ab-interno 120° Trabeculotomy: A Case Series Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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