NCT02868502

Brief Summary

The purpose of this study is to investigate the effect of trabeculectomy, glaucoma drainage devices, cyclophotocoagulation and ocular hypotensive eye-drops on IOP elevation with postural change from the sitting to supine positions in eyes with open-angle glaucoma. Patients will be assigned to the different study groups according to their past ocular history. Interventions are similar to all study group and no medical therapy alteration will be made.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

11 months

First QC Date

July 27, 2016

Last Update Submit

August 14, 2016

Conditions

Open Angle Glaucoma

Keywords

GlaucomaOpen Angle GlaucomaIntra Ocular PressureOcular Hypotensive DropsTrabeculectomyCyclophotocoagulationGlaucoma Drainage Device

Outcome Measures

Primary Outcomes (1)

  • Measurements of Intra Ocular Pressure Fluctuation with Postural Change in Eyes with Open-angle Glaucoma and Ocular Hypertension, compared to healthy subjects

    Interventions are similar for all study groups: The subject will be instructed to stay in a sitting position for 5 minutes. A topical anesthetic eye drop (oxybuprocaine hydrochloride 0.4%) will then be installed in the study eye (necessary procedure made in all IOP examinations as a regular procedure) and the IOP will be measured, in the following order by 4 tonometers: Goldmann tonometer, Pneumatonometer, Tonopen XL, ICare rebound tonometer. The subject will then lie supine for 5 minutes, afterwards will turn to the lateral decubitus position and IOP will be measured again using the same tonometers in the same manner. The difference between IOP in the sitting and lying body positions will be assessed and compared to the control group.

    Change from baseline 5 minutes following position change

Study Arms (6)

Trabeculectomy

Subjects with OAG s/p Trabeculectomy. IOP measurement in different positions.

Device: Goldmann tonometerDevice: PneumatonometerDevice: Tonopen XLDevice: ICare rebound tonometer

Ahmed Glaucoma Valve implantation

Subjects with OAG s/p Ahmed valve implantation. IOP measurement in different positions.

Device: Goldmann tonometerDevice: PneumatonometerDevice: Tonopen XLDevice: ICare rebound tonometer

Cyclophotocoagulation

Subjects with OAG s/p Cyclophotocoagulation. IOP measurement in different positions.

Device: Goldmann tonometerDevice: PneumatonometerDevice: Tonopen XLDevice: ICare rebound tonometer

Ocular hypotensive eye drops

Subjects with OAG treated with ocular hypotensive eye drops and no ocular surgical hypotensive treatments. IOP measurement in different positions.

Device: Goldmann tonometerDevice: PneumatonometerDevice: Tonopen XLDevice: ICare rebound tonometer

Ocular Hypertension

Subjects with no evidence of glaucomatous damage, but with IOP measurements above 21 mmHg.. IOP measurement in different positions.

Device: Goldmann tonometerDevice: PneumatonometerDevice: Tonopen XLDevice: ICare rebound tonometer

Control

Subjects with healthy eyes, apart for refraction errors, post cataract surgery, strabismus or amblyopia. IOP measurement in different positions.

Device: Goldmann tonometerDevice: PneumatonometerDevice: Tonopen XLDevice: ICare rebound tonometer

Interventions

Goldmann tonometerDEVICE

IOP measurement in the sitting position and lateral decubitus

Ahmed Glaucoma Valve implantationControlCyclophotocoagulationOcular HypertensionOcular hypotensive eye dropsTrabeculectomy
PneumatonometerDEVICE

IOP measurement in the sitting position and lateral decubitus

Ahmed Glaucoma Valve implantationControlCyclophotocoagulationOcular HypertensionOcular hypotensive eye dropsTrabeculectomy
Tonopen XLDEVICE

IOP measurement in the sitting position and lateral decubitus

Ahmed Glaucoma Valve implantationControlCyclophotocoagulationOcular HypertensionOcular hypotensive eye dropsTrabeculectomy
ICare rebound tonometerDEVICE

IOP measurement in the sitting position and lateral decubitus

Ahmed Glaucoma Valve implantationControlCyclophotocoagulationOcular HypertensionOcular hypotensive eye dropsTrabeculectomy

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects with open angle glaucoma with past ocular history of surgical treatment (trabeculectomy, implantation of an Ahmed glaucoma drainage device or cyclophotocoagulation) or are using ocular hypotensive eye drops and subjects with ocular hypertension.

You may qualify if:

  • OAG patients
  • Ocular Hypertension (OHT) patients
  • Healthy subjects, without any ocular pathology (except for refraction errors, past cataract surgery, strabismus or amblyopia).

You may not qualify if:

  • Other intraocular surgeries within the past 3 months
  • Illness effecting episcleral venous pressure, such as superior vena cava syndrome, thyroid eye disease, orbital masses
  • Patients who are unable to maintain supine position for 15 minutes
  • Corneal abnormalities: epithelial pathologies, corneal infection, corneal erosions, corneal scars, keratoconus, S/P corneal transplantation (lamellar/full thickness)
  • Hypersensitivity to oxybuprocaine hydrochloride

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Schulzer M, Mikelberg FS, Drance SM. Some observations on the relation between intraocular pressure reduction and the progression of glaucomatous visual loss. Br J Ophthalmol. 1987 Jul;71(7):486-8. doi: 10.1136/bjo.71.7.486.

    PMID: 3651360BACKGROUND

  • Flammer J, Robert Y, Gloor B. Influence of pindolol and timolol treatment on the visual fields of glaucoma patients. J Ocul Pharmacol. 1986 Fall;2(4):305-11. doi: 10.1089/jop.1986.2.305.

    PMID: 3503114BACKGROUND

  • Kidd MN, O'Connor M. Progression of field loss after trabeculectomy: a five-year follow-up. Br J Ophthalmol. 1985 Nov;69(11):827-31. doi: 10.1136/bjo.69.11.827.

    PMID: 4063249BACKGROUND

  • Barkana Y, Anis S, Liebmann J, Tello C, Ritch R. Clinical utility of intraocular pressure monitoring outside of normal office hours in patients with glaucoma. Arch Ophthalmol. 2006 Jun;124(6):793-7. doi: 10.1001/archopht.124.6.793.

    PMID: 16769832BACKGROUND

  • Barkana Y, Gutfreund S. Measurement of the difference in intraocular pressure between the sitting and lying body positions in healthy subjects: direct comparison of the Icare Pro with the Goldmann applanation tonometer, Pneumatonometer and Tonopen XL. Clin Exp Ophthalmol. 2014 Sep-Oct;42(7):608-14. doi: 10.1111/ceo.12272. Epub 2014 Jan 13.

    PMID: 24299102BACKGROUND

  • Weber AK, Price J. Pressure differential of intraocular pressure measured between supine and sitting position. Ann Ophthalmol. 1981 Mar;13(3):323-6.

    PMID: 7258940BACKGROUND

  • Buchanan RA, Williams TD. Intraocular pressure, ocular pulse pressure, and body position. Am J Optom Physiol Opt. 1985 Jan;62(1):59-62. doi: 10.1097/00006324-198501000-00008.

    PMID: 3976837BACKGROUND

  • Yamabayashi S, Aguilar RN, Hosoda M, Tsukahara S. Postural change of intraocular and blood pressures in ocular hypertension and low tension glaucoma. Br J Ophthalmol. 1991 Nov;75(11):652-5. doi: 10.1136/bjo.75.11.652.

    PMID: 1751457BACKGROUND

  • Liu JH, Kripke DF, Weinreb RN. Comparison of the nocturnal effects of once-daily timolol and latanoprost on intraocular pressure. Am J Ophthalmol. 2004 Sep;138(3):389-95. doi: 10.1016/j.ajo.2004.04.022.

    PMID: 15364220BACKGROUND

  • Liu JH, Medeiros FA, Slight JR, Weinreb RN. Diurnal and nocturnal effects of brimonidine monotherapy on intraocular pressure. Ophthalmology. 2010 Nov;117(11):2075-9. doi: 10.1016/j.ophtha.2010.03.026. Epub 2010 Jul 21.

    PMID: 20663566BACKGROUND

  • Tung JD, Tafreshi A, Weinreb RN, Slight JR, Medeiros FA, Liu JH. Twenty-four-hour effects of bimatoprost 0.01% monotherapy on intraocular pressure and ocular perfusion pressure. BMJ Open. 2012 Aug 23;2(4):e001106. doi: 10.1136/bmjopen-2012-001106. Print 2012.

    PMID: 22918671BACKGROUND

  • Mansouri K, Medeiros FA, Weinreb RN. Effect of glaucoma medications on 24-hour intraocular pressure-related patterns using a contact lens sensor. Clin Exp Ophthalmol. 2015 Dec;43(9):787-95. doi: 10.1111/ceo.12567. Epub 2015 Aug 16.

    PMID: 26152693BACKGROUND

  • Hirooka K, Takenaka H, Baba T, Takagishi M, Mizote M, Shiraga F. Effect of trabeculectomy on intraocular pressure fluctuation with postural change in eyes with open-angle glaucoma. J Glaucoma. 2009 Dec;18(9):689-91. doi: 10.1097/IJG.0b013e31819c49f4.

    PMID: 20010249BACKGROUND

  • Hirooka K, Tenkumo K, Nitta E, Sato S. Correlation between Intraocular Pressure Fluctuation with Postural Change and Postoperative Intraocular Pressure in Relation to the Time Course after Trabeculectomy. J Ophthalmol. 2014;2014:801967. doi: 10.1155/2014/801967. Epub 2014 Jul 17.

    PMID: 25136454BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Avner Belkin, M.D

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ortal Fogel Tempelhof, M.D

CONTACT

+972528518303talifog@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 16, 2016

Study Start

September 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 16, 2016

Record last verified: 2016-08