This is a pilot study, which will include approximately five eyes of 5 patients. This study proposes that a sustained release steroid insert (Yutiq)1 be implanted along with a glaucoma drainage device (Ahmed Glaucoma Valve (AGV) Model FP7) when the patient is undergoing glaucoma tube implant surgery or combined glaucoma tube implant and cataract surgery. The primary aim of this study is to assess the safety and efficacy (controlling intraocular pressure) of the Yutiq inserts to reduce post-operative scarring in surgical glaucoma patients. It is expected that post-operative week 12 onwards there will be a clinically and statistically significant lower IOP in the study eyes than eyes in a group undergoing the same surgery without the Yutiq insert. The estimated duration of the present study is 3 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
a sustained-release steroid insert (Yutiq)
Duke Eye Center
Durham, North Carolina, United States
Change in IOP measured using Goldman applanation tonometry
IOP in study eyes compared to eyes undergoing the same surgery without the Yutiq insert
Time frame: week 12, month 6, month 12, month 18, month 24, month 30 , month 36
Change in IOP measured using tonopen/Icare
IOP in study eyes compared to eyes undergoing the same surgery without the Yutiq insert
Time frame: week 12, month 6, month 12, month 18, month 24, month 30 , month 36
Medications usage as measured by medical record abstraction
Number of medications to control IOP in the study eye
Time frame: week 12
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Time frame: month 6
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Time frame: month 12
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Time frame: month 18
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Time frame: month 24
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Time frame: month 30
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Time frame: month 36
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Time frame: week 12
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Time frame: month 6
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Time frame: month 12
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Time frame: month 18
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Time frame: month 24
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Time frame: month 30
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Time frame: month 36
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