Different Glaucoma Treatments Effect on Intraocular Pressure Fluctuation With Postural Change in Eyes With Open-angle Glaucoma

NCT ID: NCT02868502

Last Updated: 2016-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Visual impairment and blindness due to chronic progressive optic neuropathy developing from glaucoma are major health problems worldwide.

Glaucoma is a progressive, potentially blinding disease, in which the only modifiable risk factor in intraocular pressure. In a significant proportion of patients, the disease progresses despite apparent IOP control(1-3).

One factor which may explain some of this discrepancy is a fluctuation of the IOP during the day, which may be missed in a single visit to the ophthalmologist(4). Although this fluctuation depends to some degree on daily biologic rhythms and the specific type of glaucoma, a constant significant factor responsible for this effect is the IOP-dependent changes of body posture, from sitting or standing to lying down(5). Older studies have shown IOP postural changes in the range of 4-6 mmHg(6-8). Seeing how a typical patient may spend as much as a third of his life in the supine position, knowledge of IOP in this position, and its control, are of great importance in decreasing the chance for irreversible optic nerve damage.

Several studies of Liu JH(9-11) have investigated the effect of hypotensive drops on nocturnal IOP. While prostaglandin analogues (PGA) and carbonic anhydrase inhibitors (CAI) seemed to have a significant nocturnal IOP lowering effect, the effect seen with beta blockers and alpha agonists was minimal. Mansouri et al.(12) recently showed that PGA seem to flatten the IOP-related increase when moving from the sitting to the supine position at nocturnal period, without effecting other circadian IOP-related patterns.

Hirooka Kazuyuki investigated the effect of trabeculectomy on the IOP fluctuations caused by postural changes(13-14). He showed that successful trabeculectomy, which didn't require needling, have significantly decreased the posture-induced IOP changes to less than 3 mmHg.

To the best of our knowledge there is no data regarding the effect of glaucoma drainage devices and cyclophotocoagulation on supine IOP.

The purpose of this study is to investigate the effect of different IOP lowering methods, including trabeculectomy, glaucoma drainage devices, cyclophotocoagulation and ocular hypotensive eye-drops on IOP with postural change from the sitting to supine positions in eyes with open-angle glaucoma.

Conditions

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Open Angle Glaucoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control

Subjects with healthy eyes, apart for refraction errors, post cataract surgery, strabismus or amblyopia.

IOP measurement in different positions.

Goldmann tonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Pneumatonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Tonopen XL

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

ICare rebound tonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Trabeculectomy

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

Goldmann tonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Pneumatonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Tonopen XL

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

ICare rebound tonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Ahmed Glaucoma Valve implantation

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

Goldmann tonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Pneumatonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Tonopen XL

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

ICare rebound tonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Cyclophotocoagulation

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

Goldmann tonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Pneumatonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Tonopen XL

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

ICare rebound tonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Ocular hypotensive eye drops

Subjects with OAG treated with ocular hypotensive eye drops and no ocular surgical hypotensive treatments.

IOP measurement in different positions.

Goldmann tonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Pneumatonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Tonopen XL

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

ICare rebound tonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Ocular Hypertension

Subjects with no evidence of glaucomatous damage, but with IOP measurements above 21 mmHg..

IOP measurement in different positions.

Goldmann tonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Pneumatonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Tonopen XL

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

ICare rebound tonometer

Intervention Type DEVICE

IOP measurement in the sitting position and lateral decubitus

Interventions

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Goldmann tonometer

IOP measurement in the sitting position and lateral decubitus

Intervention Type DEVICE

Pneumatonometer

IOP measurement in the sitting position and lateral decubitus

Intervention Type DEVICE

Tonopen XL

IOP measurement in the sitting position and lateral decubitus

Intervention Type DEVICE

ICare rebound tonometer

IOP measurement in the sitting position and lateral decubitus

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Avner Belkin

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Avner Belkin, M.D

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Central Contacts

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Ortal Fogel Tempelhof, M.D

Role: CONTACT

+972528518303

References

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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.

Reference Type BACKGROUND
PMID: 3651360 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3503114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4063249 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16769832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24299102 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 7258940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3976837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1751457 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15364220 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20663566 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22918671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26152693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20010249 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25136454 (View on PubMed)

Other Identifiers

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MMC-0026-16

Identifier Type: -

Identifier Source: org_study_id

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