NCT02665884

Brief Summary

Diurnal fluctuations of intraocular pressure in EX-Press Valve Blebs in Glaucoma Patients Intraocular pressure (IOP) reduction is the mainstay of glaucoma management. (1) Open-angle glaucoma (OAG) is generally managed by decreasing the intraocular pressure (IOP) to a level that the physician believes will prevent further glaucomatous damage. However, in a significant proportion of patients, the visual fields continue to deteriorate in spite of office pressures within the range of normal values (8). It has been suggested that the progressive damage in some cases could be caused by peaks of IOP or diurnal IOP variability not detected by tonometry during office hours. It is possible that certain drugs or surgical interventions are more effective than others in dampening these fluctuations. The purpose of our study is to compare the diurnal IOP fluctuations in glaucoma patients treated with medications or Ex-press filtration surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

November 29, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 28, 2016

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

November 29, 2015

Last Update Submit

January 24, 2016

Conditions

GLAUCOMA

Outcome Measures

Primary Outcomes (1)

  • Comparison of diurnal fluctuations of intraocular pressure

    Comparison of diurnal fluctuations of intraocular pressure in glaucoma patients with and without EX-Press valve surgery

    One year

Study Arms (2)

Glaucoma EX-PRESS

Glaucoma patients who underwent glaucoma surgery between the years 2014-2015 and had diurnal intraocular pressure measurements over 24 hours.

Other: Intraocular Pressure Measurement

Control Group

Glaucoma patients who had been treated with anti-glaucoma drops and had diurnal intraocular pressure measurements over 24 hours.

Other: Intraocular Pressure Measurement

Interventions

Intraocular Pressure MeasurementOTHER

Diurnal fluctuations of intraocular pressure will be measured and compared

Control GroupGlaucoma EX-PRESS

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will include 20 open-angle glaucoma (OAG) patients underwent Ex-Press filtration surgery, and 20 OAG patients treated with medications alone.

You may qualify if:

  • Glaucoma patients that underwent EX-PRESS surgery

You may not qualify if:

  • Angle closure glaucoma
  • Neovascular glaucoma
  • High refractive error

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Related Publications (13)

  • The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration.The AGIS Investigators. Am J Ophthalmol. 2000 Oct;130(4):429-40. doi: 10.1016/s0002-9394(00)00538-9.

    PMID: 11024415RESULT

  • Watson PG. When to operate on open angle glaucoma. Eye (Lond). 1987;1 ( Pt 1):51-4. doi: 10.1038/eye.1987.8.

    PMID: 2881812RESULT

  • Levene RZ. Glaucoma filtering surgery: factors that determine pressure control. Ophthalmic Surg. 1984 Jun;15(6):475-83.

    PMID: 6462607RESULT

  • Picht G, Grehn F. Classification of filtering blebs in trabeculectomy: biomicroscopy and functionality. Curr Opin Ophthalmol. 1998 Apr;9(2):2-8. doi: 10.1097/00055735-199804000-00002.

    PMID: 10180508RESULT

  • Hu CY, Matsuo H, Tomita G, Suzuki Y, Araie M, Shirato S, Tanaka S. Clinical characteristics and leakage of functioning blebs after trabeculectomy with mitomycin-C in primary glaucoma patients. Ophthalmology. 2003 Feb;110(2):345-52. doi: 10.1016/S0161-6420(02)01739-6.

    PMID: 12578779RESULT

  • DeBry PW, Perkins TW, Heatley G, Kaufman P, Brumback LC. Incidence of late-onset bleb-related complications following trabeculectomy with mitomycin. Arch Ophthalmol. 2002 Mar;120(3):297-300. doi: 10.1001/archopht.120.3.297.

    PMID: 11879132RESULT

  • Netland PA, Sarkisian SR Jr, Moster MR, Ahmed II, Condon G, Salim S, Sherwood MB, Siegfried CJ. Randomized, prospective, comparative trial of EX-PRESS glaucoma filtration device versus trabeculectomy (XVT study). Am J Ophthalmol. 2014 Feb;157(2):433-440.e3. doi: 10.1016/j.ajo.2013.09.014. Epub 2013 Nov 7.

    PMID: 24210765RESULT

  • 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: 4063249RESULT

  • DRANCE SM. DIURNAL VARIATION OF INTRAOCULAR PRESSURE IN TREATED GLAUCOMA. SIGNIFICANCE IN PATIENTS WITH CHRONIC SIMPLE GLAUCOMA. Arch Ophthalmol. 1963 Sep;70:302-11. doi: 10.1001/archopht.1963.00960050304004. No abstract available.

    PMID: 14048787RESULT

  • Zeimer RC, Wilensky JT, Gieser DK, Viana MA. Association between intraocular pressure peaks and progression of visual field loss. Ophthalmology. 1991 Jan;98(1):64-9. doi: 10.1016/s0161-6420(91)32340-6.

    PMID: 2023735RESULT

  • Asrani S, Zeimer R, Wilensky J, Gieser D, Vitale S, Lindenmuth K. Large diurnal fluctuations in intraocular pressure are an independent risk factor in patients with glaucoma. J Glaucoma. 2000 Apr;9(2):134-42. doi: 10.1097/00061198-200004000-00002.

    PMID: 10782622RESULT

  • Iliev ME, Goldblum D, Katsoulis K, Amstutz C, Frueh B. Comparison of rebound tonometry with Goldmann applanation tonometry and correlation with central corneal thickness. Br J Ophthalmol. 2006 Jul;90(7):833-5. doi: 10.1136/bjo.2005.089870. Epub 2006 May 3.

    PMID: 16672330RESULT

  • Martinez-de-la-Casa JM, Garcia-Feijoo J, Castillo A, Garcia-Sanchez J. Reproducibility and clinical evaluation of rebound tonometry. Invest Ophthalmol Vis Sci. 2005 Dec;46(12):4578-80. doi: 10.1167/iovs.05-0586.

    PMID: 16303951RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

Intraocular Pressure

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Central Study Contacts

Yuval Cohen, MD., PhD

CONTACT

0586904951dr.yuvalcohen@gmail.com

Study Design

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

Study Record Dates

First Submitted

November 29, 2015

First Posted

January 28, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

January 28, 2016

Record last verified: 2015-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)