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Primary Open Angle GlaucomaNCT02891317

Assessing Ocular Hemodynamic Response to Surgical Intervention in Glaucoma

An observational study of Primary Open Angle Glaucoma and Low Tension Glaucoma, run by University of North Carolina, Chapel Hill at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
2 participants
Where
1 siteUnited States
Study dates
8 May 2017to 12 Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UNC Kittner Eye Center

    Chapel Hill, North Carolina, 27517

Other trials in United States

About this study

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.

Read the 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.

Medical subject headings
Glaucoma, Open-Angle, Low Tension Glaucoma, Cataract, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02891317
Study groupRoleWhat they receive
Cataract Surgery OnlyTwenty-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 iStentTwenty-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 DeviceTwenty-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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 7-10 days before surgery, 6-8 weeks post-operatively

Secondary outcomes (3)
  1. Change in Optic Nerve Blood Flow

    The trends of Doppler blood flow as measured with the Bioptigen Envisu C3500 will be assessed before and after surgery. Qualitative and quantitative analysis of flow velocities and capillary density will be completed.

    Measured: 7-10 days before surgery, 6-8 weeks post-operatively

  2. Percent change in Retinal Oxygen Saturation

    Retinal oxygen saturation will be assessed before and after surgery, glaucoma patients tend to have decreased oxygen utilization, thus higher venous O2 saturation. Data will be analyzed to determine whether tissue oxygen utilization improves with surgery.

    Measured: 7-10 days before surgery, 6-8 weeks post-operatively

  3. Change in Ocular Perfusion Pressure

    Ocular perfusion pressure (OPP) is the difference between the systemic blood pressure and the intraocular pressure. We will use measurements from an ambulatory blood pressure monitor and the Triggerfish lens to calculate OPP.

    Measured: 7-10 days before surgery, 6-8 weeks post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2016 (estimated)
  2. Study start8 May 2017
  3. Primary completion12 Jun 2017
  4. Study completion12 Jun 2017

Why it stopped: Technical \& Logistical issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02891317
Sponsor's protocol ID
14-3339
Other IDs
1K23EY026098-01
Status last verified
Mar 2019
First submitted
31 Aug 2016
Last updated
5 Mar 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Open Angle Glaucoma and Low Tension Glaucoma, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Technical \& Logistical issues). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Intraocular Pressure (time frame: 7-10 days before surgery, 6-8 weeks post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.

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