The Effect of Scheduled Ripcord Removal on the Outcomes of Baerveldt 350 Implants
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | September 2013 |
| End Date: | September 19, 2017 |
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.
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.
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
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