The Effect of Scheduled Ripcord Removal on the Outcomes of Baerveldt 350 Implants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-09-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Observation

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Ripcord removal

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

Group Type EXPERIMENTAL

Ripcord removal

Intervention Type PROCEDURE

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.

Interventions

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Ripcord removal

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No