Assessing Ocular Hemodynamic Response to Surgical Intervention in Glaucoma

NCT02891317 | Terminated DMC

• 2 other identifiers: 14-33391K23EY026098-01
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (3)

Cataract Surgery Only

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.

Cataract Surgery with iStent

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.

Glaucoma Drainage Device

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Participants meeting the following surgical indications for glaucoma:
• Open angle glaucoma with uncontrolled intraocular pressure on maximum tolerated medical therapy at risk of glaucomatous vision loss, documented visual field progression, severe visual field defects threatening or involving fixation with preserved visual acuity
• Phacomorphic angle closure with clinical symptoms and/or Visual Field/Optical Coherence Tomography defects
• Other appropriate indication
• Participants willing to complete the written informed consent
• Participants willing to complete a screening visit and subsequent study visits

You may not qualify if:

• Children and adolescents
• Patients with non-phacomorphic angle closure or secondary glaucoma diagnosis
• Prior retinal or glaucoma laser or incisional surgeries
• Non-glaucomatous optic neuropathy
• Any intraocular surgery within the preceding 90 days
• Active ocular infection or inflammation
• Ocular abnormalities that preclude the necessary study related measurements and assessments
• Pre-existing medical conditions that are associated with blood pressure (BP) instability
• Medications that confound BP assessment
• Symptomatic dry eye disease
• Allergy to silicone, adhesives, diagnostic and post-surgical topical ocular medications
• Skin irritation, eczema, or other indication against wearing patches
• Vulnerable populations

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Eye Institute (NEI): collaborator
• American Glaucoma Society: collaborator

Study Sites (1)

UNC Kittner Eye Center

Chapel Hill, North Carolina, 27517, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Low Tension Glaucoma; Cataract; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases; Optic Nerve Diseases; Lens Diseases

Study Officials

• O'Rese J Knight, MD

  Unverisity of North Carolina - Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Study Start: May 8, 2017
• Primary Completion: June 12, 2017
• Study Completion: June 12, 2017
• Last Updated: March 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)