NCT01915706

Brief Summary

The purpose of this study is to compare the post-operative complication rates and surgical outcomes in patients with a Baerveldt 350 implant following scheduled rip-cord removal in clinic at post-operative week 3 versus spontaneous tube opening. Patients age 18 or greater with uncontrolled glaucoma and scheduled to undergo their first superotemporal Baerveldt 350 implant will be recruited and randomized at the time of enrollment to either scheduled ripcord removal at post-operative week 3 or no ripcord removal. Incidence of complications will be documented and compared between the 2 groups. The final intraocular pressure control between the 2 groups will also be compared in a secondary outcome analysis. This study will help to establish post-operative management guidelines to minimize complications and improve intraocular pressure lowering success following Baerveldt 350 implantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2017

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

4.1 years

First QC Date

July 31, 2013

Last Update Submit

February 28, 2018

Conditions

Glaucoma

Keywords

Glaucoma drainage deviceBaerveldt 350RipcordComplications

Outcome Measures

Primary Outcomes (1)

  • Incidence of post-operative complications

    Incidence of complications (including but not limited to shallowing of the anterior chamber, hypotony, choroidal effusion and choroidal hemorrhage) will be documented and compared between the 2 groups.

    Up to 6 months

Secondary Outcomes (1)

  • Incidence of successful intraocular pressure control

    Post-operative month 6

Study Arms (2)

Observation

NO INTERVENTION

Patients randomized to observation will be observed during the post-operative period for spontaneous Baerveldt-350 tube opening. The ripcord will not be removed unless deemed medically necessary by the study physician.

Ripcord removal

EXPERIMENTAL

Patients randomized to intervention will have their ripcords removed in clinic at post-operative week 3.

Procedure: Ripcord removal

Interventions

Ripcord removalPROCEDURE

Patients randomized to intervention will have their ripcords removed in clinic at post-operative week 3. Ripcord removal will be performed by study PI at the slit lamp with standard of care sterile technique and topical/local anesthesia. Patients will be monitored 30 minutes following ripcord removal for intraocular pressure as well as complications.

Ripcord removal

Eligibility Criteria

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

You may qualify if:

  • Men or women aged 18 years and older at screening. There is no upper age limit.
  • Inadequately controlled glaucoma refractory to maximum therapy
  • Suitable candidate for Baerveldt-350 implant in the superotemporal quadrant in the study eye, which the physician deems as medically necessary.
  • Capable and willing to provide consent

You may not qualify if:

  • Unable or unwilling to provide consent
  • Any previous ocular surgery other than cataract extraction or trabeculectomy
  • Any previous ocular surgeries in the study eye preventing placement of the Baerveldt-350 implant in the superotemporal quadrant
  • Any abnormality other than glaucoma in the study eye that could affect tonometry.
  • Presence or history of any abnormality or disorder that could interfere with the study procedure or prevent the successful completion of the study.
  • Monocularity (where best corrected visual acuity in the non-operative eye is worse than 20/200)
  • Any significant unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  • Known pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • An SJ, Wen JC, Quist MS, Mathenge EW, Vin A, Herndon LW. Scheduled Postoperative Ripcord Removal in Baerveldt 350 Implants: A Prospective, Randomized Trial. J Glaucoma. 2019 Feb;28(2):165-171. doi: 10.1097/IJG.0000000000001133.

    PMID: 30689608DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Leon Herndon, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 5, 2013

Study Start

September 1, 2013

Primary Completion

September 19, 2017

Study Completion

September 19, 2017

Last Updated

March 1, 2018

Record last verified: 2018-02

Locations

US(1)