NCT02891317

Assessing Ocular Hemodynamic Response to Surgical Intervention in Glaucoma

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Purpose: Glaucoma is the leading cause of irreversible blindness worldwide and the third leading cause of vision loss in the United States. It is estimated that greater than 4.3 million Americans will have glaucoma in 2030. The treatment options are topical medications, laser surgery, and incisional surgery. The goal of therapy is to lower intraocular pressure (IOP). Despite adequate lowering of IOP, many patients continue to lose vision due to progressive glaucomatous optic atrophy. This is likely related to the poor understanding of glaucoma pathogenesis. There are two theories which explain the mechanism of primary open angle glaucoma (POAG). The mechanical theory posits that intraocular pressure (IOP) can produce optic nerve damage through biomechanical or structural factors. All current therapeutic interventions are aimed at this particular mechanism. The vascular theory suggests that compromise of the optic nerve microvasculature induces glaucomatous optic nerve damage. There is a significant body of literature supporting the role of ocular hemodynamic (OHD) changes in the development and progression of glaucoma. However, there have been limited investigations of the effect of surgical interventions on OHD. This is primarily due to a lack of non-invasive, cost-effective methods of assessing OHD factors. Today, the technology exists to assess these factors in such a manner. Thus, the purpose of this study is to assess the response of OHD factors to surgical intervention in glaucoma patients. Participants: Seventy-five participants with varying degrees of open angle glaucoma (OAG) that meet clinical criteria for cataract or glaucoma surgery will be recruited from the glaucoma clinics at the University of North Carolina (UNC) Kittner Eye Center. Once they have been determined to be eligible, they will be assigned to one of three groups based upon surgical indication. Group 1 is cataract surgery only. Group 2 is cataract surgery with iStent (Glaukos Corp., Laguna Hills, CA) implantation. Group 3 is implantation of a glaucoma drainage device. 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. Procedures (methods): Participants will undergo assessment of 24 hour IOP and ocular perfusion pressure (OPP), retinal oxygen saturation (RSO2), and optic nerve blood flow (ONBF), within 10 days of their assigned surgical procedure and again 6-8 weeks post-operatively. Ambulatory IOP and OPP: IOP will be measured using the Triggerfish® (Sensimed AG, Lausanne, Switzerland) contact lens sensor (CLS) every five minutes. Blood pressure (BP) will be measured with an ambulatory BP measure (ABPM) every 30 minutes during the day and every hour overnight. Participants will have the CLS and ABPM placed by study personnel, wear them for 24 hours assuming their typical daily activity and sleep regimen, then return to clinic the following day to have the devices removed. Optic Nerve Blood Flow and Retinal Oximetry: Prior to placement of the CLS and ABPM participants will undergo assessment of the ONBF using Doppler spectral domain optical coherence tomography (SD-OCT) and RSO2 using the Oxymap T1 (Oxymap, Reykjavik, Iceland) retinal oximeter.

Conditions

• Primary Open Angle Glaucoma
• Low Tension Glaucoma
• Cataract
• Ocular Hypertension

Timeline

• Start date: 2017-05-08
• Primary completion: 2017-06-12
• Completion: 2017-06-12
• First posted: 2016-09-07
• Last updated: 2019-03-05

Locations

1 site across 1 country: United States