GLAUCOMA 1, OPEN ANGLE, D (Disorder)NCT07803536
Effect of Late Ripcord Removal From Glaucoma Drainage Device
A study testing Ripcord removal in people with GLAUCOMA 1, OPEN ANGLE, D (Disorder) and Glaucoma, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GLAUCOMA 1, OPEN ANGLE, D (Disorder), Glaucoma
- What is being tested?
- Ripcord removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active ocular infection or conjunctivitis in either eye
- Inability to undergo ripcord removal procedure
- Scheduled for further glaucoma surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke University Eye Center
Durham, North Carolina, 27705
Jonathan Shepherd, 919-681-3937, j_shepherd0829@email.campbell.edu
Leon W Herndon, MD
About this study
Official title: Prospective, Single-arm Interventional Study to Determine Effect of Late Ripcord Removal From Glaucoma Drainage Device
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.
- Conditions
- GLAUCOMA 1, OPEN ANGLE, D (Disorder), Glaucoma
- Being tested
- Ripcord removal
- Keywords
- glaucoma drainage device, ripcord
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ripcord removalProcedure or surgery
Patients who have had a ripcord in place for greater than 3 months postoperatively will undergo ripcord removal in the office.
| Study group | Role | What they receive |
|---|---|---|
| Ripcord removal | Experimental | Not described Receives: Procedure: Ripcord removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intraocular pressure (IOP)
Change in intraocular pressure
Measured: Immediately after, 1 week, 6 weeks and 3-month intervals
Secondary outcomes (1)
Change in Drop Burden
Measured by the number of participants who miss drop doses
Measured: 1 week, 6 week and 3 month interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GLAUCOMA 1, OPEN ANGLE, D (Disorder)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leon W Herndon, MD, Principal investigator, Duke University Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803536
- Sponsor's protocol ID
- Pro00120427
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm Interventional Study to Determine Effect of Late Ripcord Removal From Glaucoma Drainage Device
- ClinicalTrials.gov ID
- NCT07803536
- Acronym / sponsor ID
- Pro00120427
- Conditions
- GLAUCOMA 1, OPEN ANGLE, D (Disorder), Glaucoma
- Keywords
- glaucoma drainage device, ripcord
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ripcord removal | Experimental | Procedure: Ripcord removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Active ocular infection or conjunctivitis in either eye
- Inability to undergo ripcord removal procedure
- Scheduled for further glaucoma surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ripcord removalPatients who have had a ripcord in place for greater than 3 months postoperatively will undergo ripcord removal in the office. | Procedure or surgery | Ripcord removal |
Primary outcome
Change in intraocular pressure (IOP)
Time frame: Immediately after, 1 week, 6 weeks and 3-month intervals
Change in intraocular pressure
1 secondary outcome
Change in Drop Burden
Time frame: 1 week, 6 week and 3 month interval
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leon W Herndon, MD principal investigator
Duke University Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ripcord removal in people with GLAUCOMA 1, OPEN ANGLE, D (Disorder) and Glaucoma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Shepherd ((919) 681-3937, j_shepherd0829@email.campbell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intraocular pressure (IOP) (time frame: Immediately after, 1 week, 6 weeks and 3-month intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.