Open Angle Glaucoma Clinical Trial
Official title:
The Effect of Trabeculectomy, Glaucoma Drainage Device, Cyclophotocoagulation, and Ocular Hypotensive Eye-drops on Intraocular Pressure Fluctuation With Postural Change in Eyes With Open-angle Glaucoma
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.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 95 Years |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Meir Medical Center |
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. — View Citation
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 Experiment Ophthalmol. 2014 Sep-Oct;42(7):608-14. doi: 10.1111/ceo.12272. Epub 2014 Jan 13. — View Citation
Buchanan RA, Williams TD. Intraocular pressure, ocular pulse pressure, and body position. Am J Optom Physiol Opt. 1985 Jan;62(1):59-62. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Mansouri K, Medeiros FA, Weinreb RN. Effect of glaucoma medications on 24-hour intraocular pressure-related patterns using a contact lens sensor. Clin Experiment Ophthalmol. 2015 Dec;43(9):787-95. doi: 10.1111/ceo.12567. Epub 2015 Aug 16. — View Citation
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. — View Citation
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). pii: e001106. doi: 10.1136/bmjopen-2012-001106. Print 2012. — View Citation
Weber AK, Price J. Pressure differential of intraocular pressure measured between supine and sitting position. Ann Ophthalmol. 1981 Mar;13(3):323-6. — View Citation
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. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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