Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients
NCT ID: NCT04609345
Last Updated: 2020-10-30
Study Results
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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UNKNOWN
400 participants
OBSERVATIONAL
2020-11-30
2021-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* 2\) On anti-glaucoma medications for \>6 months
* 3\) IOP ≤ 21 mm Hg in the study eye at the screening examination (under treatment)
* 4\) If only one eye is eligible, it is to be evaluated. If both eyes are eligible, then the eye with a higher NEI score will be selected for evaluation.
* 5\) A best-corrected visual acuity score of 6/36 on the Snellen Chart, or better in each eye.
Exclusion Criteria
* 2\) Those with severe visual field disorder (mean deviation of 20 dB or worse)
* 3\) Those with a history of ocular surgeries (intraocular surgery including ocular laser treatment which may affect the patient's ocular surface condition) within 6 months prior to the study initiation.
* 4\) Those with a history of glaucoma surgery
* 5\) Those with a history of corneal refractive surgery
* 6\) Those with severe dry eye associated with systemic disorders, or in need of drugs to treat dry eye
* 7\) Those with ocular allergy, ocular infection or ocular inflammation
* 8\) Those using eye drops for other ocular comorbidities
* 9\) Those who need to use systemic or ophthalmic steroids (excluding topical skin steroidal ointment)
* 10\) Female patients who are pregnant, nursing or lactating
* 11\) Those who use contact lenses
* 12\) Any corneal abnormality or other corneal comorbidity condition preventing reliable applanation tonometry
* 13\) Those on oral antihistamine, antipsychotic or anti-depressant drugs.
21 Years
ALL
No
Sponsors
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Santen Pharma Malaysia Sdn Bhd
INDUSTRY
Responsible Party
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Dr. Gan Eng Hui
Principal Investigator
Principal Investigators
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Eng Hui Gan, Specialist
Role: PRINCIPAL_INVESTIGATOR
International Specialist Eye Centre (ISEC)
Central Contacts
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References
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Harasymowycz P, Birt C, Gooi P, Heckler L, Hutnik C, Jinapriya D, Shuba L, Yan D, Day R. Medical Management of Glaucoma in the 21st Century from a Canadian Perspective. J Ophthalmol. 2016;2016:6509809. doi: 10.1155/2016/6509809. Epub 2016 Nov 8.
Jonas JB, Aung T, Bourne RR, Bron AM, Ritch R, Panda-Jonas S. Glaucoma. Lancet. 2017 Nov 11;390(10108):2183-2193. doi: 10.1016/S0140-6736(17)31469-1. Epub 2017 May 31.
Perez-Bartolome F, Martinez-de-la-Casa JM, Arriola-Villalobos P, Fernandez-Perez C, Polo V, Garcia-Feijoo J. Ocular Surface Disease in Patients under Topical Treatment for Glaucoma. Eur J Ophthalmol. 2017 Nov 8;27(6):694-704. doi: 10.5301/ejo.5000977.
Mathews PM, Ramulu PY, Friedman DS, Utine CA, Akpek EK. Evaluation of ocular surface disease in patients with glaucoma. Ophthalmology. 2013 Nov;120(11):2241-8. doi: 10.1016/j.ophtha.2013.03.045. Epub 2013 May 25.
Saade CE, Lari HB, Berezina TL, Fechtner RD, Khouri AS. Topical glaucoma therapy and ocular surface disease: a prospective, controlled cohort study. Can J Ophthalmol. 2015 Apr;50(2):132-6. doi: 10.1016/j.jcjo.2014.11.006.
Inoue K. Managing adverse effects of glaucoma medications. Clin Ophthalmol. 2014 May 12;8:903-13. doi: 10.2147/OPTH.S44708. eCollection 2014.
Ramli N, Supramaniam G, Samsudin A, Juana A, Zahari M, Choo MM. Ocular Surface Disease in Glaucoma: Effect of Polypharmacy and Preservatives. Optom Vis Sci. 2015 Sep;92(9):e222-6. doi: 10.1097/OPX.0000000000000542.
Garcia-Feijoo J, Sampaolesi JR. A multicenter evaluation of ocular surface disease prevalence in patients with glaucoma. Clin Ophthalmol. 2012;6:441-6. doi: 10.2147/OPTH.S29158. Epub 2012 Mar 22.
Ogawa Y, Kim SK, Dana R, Clayton J, Jain S, Rosenblatt MI, Perez VL, Shikari H, Riemens A, Tsubota K. International Chronic Ocular Graft-vs-Host-Disease (GVHD) Consensus Group: proposed diagnostic criteria for chronic GVHD (Part I). Sci Rep. 2013 Dec 5;3:3419. doi: 10.1038/srep03419.
Sencanic I, Gazibara T, Dotlic J, Stamenkovic M, Jaksic V, Bozic M, Grgurevic A. Validation of the Glaucoma Quality of Life-15 Questionnaire in Serbian language. Int J Ophthalmol. 2018 Oct 18;11(10):1674-1684. doi: 10.18240/ijo.2018.10.16. eCollection 2018.
Takamura E, Uchio E, Ebihara N, Ohno S, Ohashi Y, Okamoto S, Kumagai N, Satake Y, Shoji J, Nakagawa Y, Namba K, Fukagawa K, Fukushima A, Fujishima H; Japanese Society of Allergology. Japanese guideline for allergic conjunctival diseases. Allergol Int. 2011 Mar;60(2):191-203. doi: 10.2332/allergolint.11-RAI-0335.
Masumoto H, Tabuchi H, Yoneda T, Nakakura S, Ohsugi H, Sumi T, Fukushima A. Severity Classification of Conjunctival Hyperaemia by Deep Neural Network Ensembles. J Ophthalmol. 2019 Jun 2;2019:7820971. doi: 10.1155/2019/7820971. eCollection 2019.
Chan EW, Li X, Tham YC, Liao J, Wong TY, Aung T, Cheng CY. Glaucoma in Asia: regional prevalence variations and future projections. Br J Ophthalmol. 2016 Jan;100(1):78-85. doi: 10.1136/bjophthalmol-2014-306102. Epub 2015 Jun 25.
Holly FJ, Lamberts DW, Esquivel ED. Kinetics of capillary tear flow in the Schirmer strip. Curr Eye Res. 1982;2(1):57-70. doi: 10.3109/02713688208998380.
Miyake H, Kawano Y, Tanaka H, Iwata A, Imanaka T, Nakamura M. Tear volume estimation using a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients. Clin Ophthalmol. 2016 May 13;10:879-86. doi: 10.2147/OPTH.S105275. eCollection 2016.
Bourne RRA, Kaarniranta K, Lorenz K, Traverso CE, Vuorinen J, Ropo A. Changes in ocular signs and symptoms in patients switching from bimatoprost-timolol to tafluprost-timolol eye drops: an open-label phase IV study. BMJ Open. 2019 Apr 2;9(4):e024129. doi: 10.1136/bmjopen-2018-024129.
Related Links
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American Academy of Ophthalmology
Other Identifiers
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CT20-004
Identifier Type: -
Identifier Source: org_study_id