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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915706
• Other study ID #: Pro00047845
• Status: Completed
• Phase: N/A
• First received: July 31, 2013
• Last updated: February 28, 2018
• Start date: September 2013
• Est. completion date: September 19, 2017

Study information

• Verified date: February 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 19, 2017
• Est. primary completion date: September 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Duke Eye Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of successful intraocular pressure control	Final intraocular pressure at post-operative month 6 will be assessed and incidence of successful intraocular pressure control will be compared. Successful intraocular pressure control is defined as unqualified when the intraocular pressure is between 6 and 18 mmHg or a 25% reduction from the pre-surgical intraocular pressure without medication and qualified when pressure-lowering therapies are required to maintain intraocular pressure at that level.	Post-operative month 6