Diurnal Fluctuations of Intraocular Pressure in EX-Press Valve Blebs in Glaucoma Patients
NCT ID: NCT02665884
Last Updated: 2016-01-28
Study Results
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Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2016-02-29
2017-02-28
Brief Summary
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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.
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Detailed Description
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Department of Ophthalmology, Hillel-Yaffe Medical Center, affiliated with the Bruce Rappaport School of Medicine, The Technion, Haifa, Israel
Introduction:
Intraocular pressure (IOP) reduction is the mainstay of glaucoma management. (1) Medication alone is sometimes not sufficient to reduce excessively high IOP, and pharmaceutical intolerance may develop or damage can occur to the optic nerve, warranting surgical intervention. (2) The filtering bleb is considered to be the cornerstone of IOP control after glaucoma filtration surgery drainage device implantation. (3) It enables the flow of the aqueous humor from the anterior chamber to the subconjunctiva, episclera, sclera and choroid, thereby lowering the IOP. (4-6) Filtration and drainage devices, such as the EX-Press device (Alcon Laboratories, Fort Worth, Texas, USA), offer a surgical alternative to glaucoma medical therapy. (7) 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. (9, 10) In another study, Asrani et al. (11) showed that IOP fluctuations are an independent risk factor in patients with glaucoma and as such may need to be treated specifically. 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.
Materials and Methods The study will include 20 open-angle glaucoma (OAG) patients underwent Ex-Press filtration surgery, and 20 OAG patients treated with medications alone. All patients will have 12 IOP measurements with 2 hours interval, starting at 10 AM until 10 AM of the following morning.
ICARE® PRO tonometer (Icare Finland Oy, Espoo, Finland) will be used for the measurement of IOP. The rebound motion of its light weighted probe will be recorded during contact of the probe with the cornea. (12, 13) The rate of deceleration of the probe is a function of IOP. The ICARE® PRO has a built-in inclination sensor that allows downward measurement of the eye in the supine position as well as in the normal upright sitting position. ICARE® PRO allows for measurement of IOP in the seated and supine positions. During IOP recording, patients will be supine or upright, and the tip of the probe will be applied perpendicular to the cornea. Two markers engraved on the piston of the probe indicated its ideal positioning. The reliability of the measurement is displayed on the ICARE® PRO tonometer screen and guided our measurements.
Fluctuations in IOP will be compared between the Ex-press filtration surgery eye and the fellow (intra-group comparison). Inter-group comparison of IOP fluctuation will be performed between the Ex-press filtration surgery eye and medically treated eye of different patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Glaucoma EX-PRESS
Glaucoma patients who underwent glaucoma surgery between the years 2014-2015 and had diurnal intraocular pressure measurements over 24 hours.
Intraocular Pressure Measurement
Diurnal fluctuations of intraocular pressure will be measured and compared
Control Group
Glaucoma patients who had been treated with anti-glaucoma drops and had diurnal intraocular pressure measurements over 24 hours.
Intraocular Pressure Measurement
Diurnal fluctuations of intraocular pressure will be measured and compared
Interventions
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Intraocular Pressure Measurement
Diurnal fluctuations of intraocular pressure will be measured and compared
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Neovascular glaucoma
* High refractive error
30 Years
80 Years
ALL
No
Sponsors
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Hillel Yaffe Medical Center
OTHER_GOV
Responsible Party
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Locations
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Hillel Yaffe Medical Center
Hadera, , Israel
Countries
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Central Contacts
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References
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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.
Watson PG. When to operate on open angle glaucoma. Eye (Lond). 1987;1 ( Pt 1):51-4. doi: 10.1038/eye.1987.8.
Levene RZ. Glaucoma filtering surgery: factors that determine pressure control. Ophthalmic Surg. 1984 Jun;15(6):475-83.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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0085-15-HYMC
Identifier Type: -
Identifier Source: org_study_id
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