Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients

Ocular Hypertension Clinical Trial

Official title:

Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04609345
• Other study ID #: CT20-004
• Status: Not yet recruiting
• Start date: November 2020
• Est. completion date: May 2021

Study information

• Verified date: October 2020
• Source: Santen Pharma Malaysia Sdn Bhd
• Contact: Dr. Gan
• Phone: 603-22848989
• Email: ganenghui[@]yahoo.com.my
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, multi-centre, cross sectional observational study to determine the prevalence of ocular surface disease (OSD) in glaucoma patients, nationwide. The study also analyses sub group of OSD prevalence, stratified according to the treatment types (i.e. preserved, preservative-free, and combination of preservative-free and preserved eyedrops), and illustrates the patient perspective on OSD.

Description:

For this prospective, multi-centre, cross sectional observational study, patients who attend routine eye examination at the medical institutions and who have been diagnosed with primary open-angle glaucoma, primary angle-closure glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or ocular hypertension will be studied. The medical institutions are selected across different regions of Malaysia to assess the nationwide prevalence of OSD in glaucoma patients. The routine assessments include Corneal Evaluation, Tear Break-Up Time (TBUT), Hyperemia and Schirmer's test whereby the data from these assessments will be collected and analyzed. The study will also includes Symptom Evaluation and Questionnaire feedback.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: May 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 1) Age of 21 years or older and those who can provide informed consent.
• 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:

• 1) Those with secondary ocular hypertension or glaucoma
• 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.

Related Conditions & MeSH terms

• Exfoliation Syndrome
• Glaucoma
• Glaucoma, Angle-Closure
• Glaucoma, Open-Angle
• Ocular Hypertension
• Pigment Dispersion Glaucoma
• Primary Angle-Closure Glaucoma
• Primary Open-angle Glaucoma
• Pseudoexfoliation Glaucoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santen Pharma Malaysia Sdn Bhd

References & Publications (16)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2016 Nov 8. Review. — View Citation

Holly FJ, Lamberts DW, Esquivel ED. Kinetics of capillary tear flow in the Schirmer strip. Curr Eye Res. 1982;2(1):57-70. — View Citation

Inoue K. Managing adverse effects of glaucoma medications. Clin Ophthalmol. 2014 May 12;8:903-13. doi: 10.2147/OPTH.S44708. eCollection 2014. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Pérez-Bartolomé F, Martínez-de-la-Casa JM, Arriola-Villalobos P, Fernández-Pérez C, Polo V, García-Feijoó 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluorescein staining score (NEI/I)	The fluorescein stained area of the cornea and conjunctiva will be measured according to the National Eye Institute/Industry (NEI/I) method.	1 day
Primary	Tear Break-Up Time (TBUT)	The time (in seconds) until the tear film breaks and the corneal surface is exposed will be measured using a slitlamp microscope.	1 day
Primary	Hyperemia score	Bulbar and palpebral conjunctiva will be examined using the reference photographs and a 4-step scale. This 4-step scale is cited from the clinical evaluation criteria of Japanese Guideline for Allergic Conjunctival Diseases.	1 day
Primary	Schirmer's score	The test allows the water in tears to travel along the length of a paper test strip.	1 day
Secondary	Symptom Evaluation	Subjects will be evaluated for the presence of symptoms such as irritation/burning/stinging, foreign body sensation, tearing, itching and dry eye sensation.	1 day
Secondary	Questionnaire feedback	Ocular Surface Disease Index (OSDI) patient questionnaire, Glaucoma QOL-15 questionnaire and Patient Experience Questionnaire (PEQ)	1 day

External Links

•   American Academy of Ophthalmology