Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients
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| ClinicalTrials.gov Identifier: NCT04609345 |
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Recruitment Status :
Not yet recruiting
First Posted : October 30, 2020
Last Update Posted : October 30, 2020
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Sponsor:
Santen Pharma Malaysia Sdn Bhd
Information provided by (Responsible Party):
Dr. Gan Eng Hui, International Specialist Eye Centre
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Brief 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.
| Condition or disease |
|---|
| Primary Open-angle Glaucoma Primary Angle-Closure Glaucoma Pseudoexfoliation Glaucoma Pigment Dispersion Glaucoma Ocular Hypertension |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 400 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Cross-Sectional |
| Official Title: | Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients |
| Estimated Study Start Date : | November 2020 |
| Estimated Primary Completion Date : | April 2021 |
| Estimated Study Completion Date : | May 2021 |
Primary Outcome Measures :
- Fluorescein staining score (NEI/I) [ Time Frame: 1 day ]The fluorescein stained area of the cornea and conjunctiva will be measured according to the National Eye Institute/Industry (NEI/I) method.
- Tear Break-Up Time (TBUT) [ Time Frame: 1 day ]The time (in seconds) until the tear film breaks and the corneal surface is exposed will be measured using a slitlamp microscope.
- Hyperemia score [ Time Frame: 1 day ]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.
- Schirmer's score [ Time Frame: 1 day ]The test allows the water in tears to travel along the length of a paper test strip.
Secondary Outcome Measures :
- Symptom Evaluation [ Time Frame: 1 day ]Subjects will be evaluated for the presence of symptoms such as irritation/burning/stinging, foreign body sensation, tearing, itching and dry eye sensation.
- Questionnaire feedback [ Time Frame: 1 day ]Ocular Surface Disease Index (OSDI) patient questionnaire, Glaucoma QOL-15 questionnaire and Patient Experience Questionnaire (PEQ)
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| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients who attend routine eye examination at the medical institutions will be studied. The medical institutions are selected across different regions of Malaysia to assess the nationwide prevalence of OSD in glaucoma patients.
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04609345
Contacts
| Contact: Dr. Gan | 603-22848989 | ganenghui@yahoo.com.my | |
| Contact: Veni | 603-22763333 | veni.venusha.sakti@santen.com |
Sponsors and Collaborators
Santen Pharma Malaysia Sdn Bhd
Investigators
| Principal Investigator: | Eng Hui Gan, Specialist | International Specialist Eye Centre (ISEC) |
Additional Information:
Publications:
Publications:
| Responsible Party: | Dr. Gan Eng Hui, Principal Investigator, International Specialist Eye Centre |
| ClinicalTrials.gov Identifier: | NCT04609345 |
| Other Study ID Numbers: |
CT20-004 |
| First Posted: | October 30, 2020 Key Record Dates |
| Last Update Posted: | October 30, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | To be confirmed |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Glaucoma Glaucoma, Open-Angle Ocular Hypertension Glaucoma, Angle-Closure |
Exfoliation Syndrome Eye Diseases Iris Diseases Uveal Diseases |