Study Stopped
Technical \& Logistical issues
Sponsor study identifier
Secondary identifiers
observational
2
1 country
1
Study Start
May 8, 2017
Actual (reported)Primary Completion
June 12, 2017
Actual (reported)Study Completion
June 12, 2017
Actual (reported)The purpose of this study is to assess how surgical interventions in glaucoma affect 24-hour intraocular pressure, 24-hour ocular perfusion pressure, optic nerve blood flow, and retinal oxygen saturation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 12, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 31, 2016
Actual (reported)September 7, 2016
Actual (reported)May 8, 2017
Actual (reported)June 12, 2017
Actual (reported)June 12, 2017
Actual (reported)Change in Intraocular Pressure
Trends in 24 hr IOP will be assessed using the Triggerfish contact lens system. Subjects will wear the lens on the surgical eye before and after surgery. Intraday and nocturnal trends will be analyzed. Additionally, ocular biometric measurements will be acquired and used in conjunction with the Triggerfish lens to develop a conversion factor for Triggerfish measurements (mV Eq) to intraocular pressure measurements (mmHg).
7-10 days before surgery, 6-8 weeks post-operatively
Change in Optic Nerve Blood Flow
7-10 days before surgery, 6-8 weeks post-operatively
Percent change in Retinal Oxygen Saturation
7-10 days before surgery, 6-8 weeks post-operatively
Change in Ocular Perfusion Pressure
7-10 days before surgery, 6-8 weeks post-operatively
Twenty-five participants with mild or moderate open angle glaucoma (OAG) controlled by medication with a visually significant cataract that meets clinical criteria for cataract surgery will be recruited from the glaucoma clinics at the UNC Kittner Eye Center. Patients who are consented for cataract surgery only (Group 1) will be recruited to this group. Each procedure will be completed in a standardized fashion with standardization of the post-operative medications. An effort will be made to gender and age match each surgical group as well as provide reasonable racial and ethnic diversity.
Twenty-five participants with mild or moderate open angle glaucoma (OAG) that meets clinical criteria for cataract surgery with implantation of an iStent trabecular micro-bypass shunt will be recruited from the glaucoma clinics at the UNC Kittner Eye Center. Patients who are consented for cataract surgery with iStent (Glaukos Corp., Laguna Hills, CA) implantation (Group 2) will be recruited to this group. Each procedure will be completed in a standardized fashion with standardization of the post-operative medications. An effort will be made to gender and age match each surgical group as well as provide reasonable racial and ethnic diversity.
Twenty-five participants with moderate or severe open angle glaucoma (OAG) that meets clinical criteria for implantation of a glaucoma drainage device (Group 3) will be recruited from the glaucoma clinics at the UNC Kittner Eye Center. Patients who are consented for implantation of a glaucoma drainage device (Group 3) will be recruited to this group. There will be 25 participants in each of the groups. Each procedure will be completed in a standardized fashion with standardization of the post-operative medications. An effort will be made to gender and age match each surgical group as well as provide reasonable racial and ethnic diversity.
Participants who are clinically indicated and already scheduled to undergo one of the following surgical interventions: i) phacoemulsification with intraocular lens implantation, ii) phacoemulsification with intraocular lens and iStent implantation, and iii) glaucoma drainage device (GDD) implantation will be recruited from the glaucoma clinics of the University of North Carolina (UNC) Kittner Eye Center. Patients, 18 - 99, male and female, from every race and ethnicity will be recruited to participate.
UNC Kittner Eye Center
Chapel Hill, North Carolina, 27517, United States
O'Rese J Knight, MD
Unverisity of North Carolina - Chapel Hill
2 participants (actual enrollment reported by the registry).
First Submitted
August 31, 2016
First Posted
September 7, 2016
Study Start
May 8, 2017
Actual (reported)An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert
Contact the study team to confirm eligibility.
Primary Completion
June 12, 2017
Actual (reported)Study Completion
June 12, 2017
Actual (reported)Last Updated
March 5, 2019
Record last verified: 2019-03
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Source: ClinicalTrials.gov.
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