Changes in Corneal Endothelial Cell Density After Transscleral ab Interno Glaucoma Gel Stent Implantation

NCT04547036 | Completed Results FDA Device

• 1 other identifier: 0010152018
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the change of endothelial cell count after XEN45 in patients with or without cataract operation.

Conditions

Glaucoma; Endothelial Cell Loss, Corneal

Outcome Measures

Primary Outcomes (1)

• Endothelial Cell Count Change

  The primary endpoint is the change of central endothelial cell density compared to preoperative data.

  baseline compared to 1-5 years postoperative

Study Arms (1)

Endothelial cell count measurment

Device: XEN45

Interventions

XEN45 DEVICE

Up to 140 consecutive patients with preoperatively recorded endothelial cell counts will be summoned to a consecutive endothelial cell count record and measurement of central corneal thickness postoperatively.

Endothelial cell count measurment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 140 consecutive patients with preoperatively recorded endothelial cell counts will be summoned to a consecutive endothelial cell count record and measurement of central corneal thickness postoperatively.

You may qualify if:

• Open Angle Glaucoma
• History past XEN45 implantation with or without combined cataract procedure
• Available preoperative endothelial cell count data not older than 1 year before XEN operation without any operation between the day of data record and XEN45 operation.
• Age 18 years or older and of legal age of consent
• Signed written informed consent
• Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Sponsors & Collaborators

• Paracelsus Medical University: lead

Study Sites (1)

Dept. Ophthalmology and Optometry Paracelsus Medical University

Salzburg, 5020, Austria

Location

MeSH Terms

Conditions

Glaucoma; Corneal Endothelial Cell Loss

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Corneal Diseases; Eye Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: PD Dr. Markus Lenzhofer PhD FEBO
• Organization: Dept. Ophthalmology at Paracelsus Medical University Salzburg

m.lenzhofer@salk.at

+43 57255

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Herbert Reitsamer

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 14, 2020
• Study Start: January 30, 2020
• Primary Completion: January 31, 2021
• Study Completion: April 30, 2021
• Last Updated: July 13, 2021
• Results First Posted: July 13, 2021

Record last verified: 2021-07

Locations

AU (1)