NCT07803536

Brief Summary

This is a research study to find out if removing the ripcord from a glaucoma drainage device more than 3 months after it has been placed has any effect on intraocular pressure. Participation in research studies is voluntary. The ripcord will be removed at a routine glaucoma care visit and intraocular pressure will be measured before removal, 30 minutes following, and at 1 week, 6 weeks and 3-month intervals during regular clinic visits.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Dec 2028

First Submitted

Initial submission to the registry

August 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

August 31, 2026

Last Update Submit

August 31, 2026

Conditions

GLAUCOMA 1, OPEN ANGLE, D (Disorder)Glaucoma

Keywords

glaucoma drainage deviceripcord

Outcome Measures

Primary Outcomes (1)

  • Change in intraocular pressure (IOP)

    Change in intraocular pressure

    Immediately after, 1 week, 6 weeks and 3-month intervals

Secondary Outcomes (1)

  • Change in Drop Burden

    1 week, 6 week and 3 month interval

Study Arms (1)

Ripcord removal

EXPERIMENTAL
Procedure: Ripcord removal

Interventions

Ripcord removalPROCEDURE

Patients who have had a ripcord in place for greater than 3 months postoperatively will undergo ripcord removal in the office.

Ripcord removal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Placement of Ahmed Clear Path or Baervelt drainage device with ripcord \> 3 months
  • Diagnosis of Glaucoma, under active management at Duke Eye Center Glaucoma Clinic
  • Ripcord suture still in place and accessible for removal
  • Able to provide written informed consent
  • IOP \> 10 mm Hg

You may not qualify if:

  • Active ocular infection or conjunctivitis in either eye
  • Inability to undergo ripcord removal procedure
  • Scheduled for further glaucoma surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Eye Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Leon W Herndon, MD

    Duke University Eye Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Shepherd

CONTACT

(919) 681-3937j_shepherd0829@email.campbell.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 3, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

September 3, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)