GlaucomaNCT01841580
Proteomic Profiles in Trabeculectomy Patients
An observational study of Glaucoma, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
Approximately 70 million people world-wide are affected with glaucoma, of whom 6.7 million have bilateral blindness.5 Elevated intro-ocular pressure is the major modifiable risk factor in glaucoma, and reducing intraocular pressure to a consistently low level can delay disease progression and therefore, blindness.6… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Glaucoma
- How many people
- 36 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2013to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 120 patients will be recruited for this study
Who may be able to join
- 120 patients will be recruited from glaucoma clinics in SNEC
- Patients age ≥ 21 years old
- Patients who require trabeculectomy operation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Singapore National Eye Centre/ Singapore Eye Research Institute
Singapore, 168751
About this study
Official title: Long-term Observation of Tear Proteomic Profiles and Ocular Surface in Trabeculectomy Patients Before and After Surgery
Approximately 70 million people world-wide are affected with glaucoma, of whom 6.7 million have bilateral blindness.5 Elevated intro-ocular pressure is the major modifiable risk factor in glaucoma, and reducing intraocular pressure to a consistently low level can delay disease progression and therefore, blindness.6 Topical intraocular pressure -lowering medication remains the first-line treatment for glaucoma, with surgical intervention playing a secondary role in cases suboptimally controlled with medication alone.
In this study, we plan to assess the change in tear proteins in trabeculectomy patients before and after operations. It is hoped that this study could help us gain more understanding of the possible mechanism accounting for the development of dry eye disease in glaucoma patients, which could help us develop better screening modalities and therapeutic agents for glaucoma patients at risk to prevent the development of dry eye disease.
Read the detailed description
Study Objectives and Purpose
There are two primary aims in this study:
- To assess changes in the tear proteomic profiles in pre-trabeculectomy and post-trabeculectomy patients
- To assess the changes in clinical signs of the eye and tear film as well as dry eye symptoms.
Study Material Human Tears will be collected from patients in SNEC clinic
Study Design:
120 patients will be recruited for this study (details as described below). Schirmers I test, Tear Osmolarity, Tear Break Up Time (TBUT), Anterior segment optical coherence tomography (ASOCT) and Impression cytology will be done during the study visits. Subjective symptom and severity of dry eye disease will be assessed through Visual Analog Scale (VAS).
No. of visits:
There will be 4 visits in this study. Visit 1: Pre-trabeculectomy operation Visit 2: 6 month after trabeculectomy surgery Visit 3: 1 year after trabeculectomy surgery Visit 4: 3 years after trabeculectomy surgery
Selection and Withdrawal of Subjects Recruitment Criteria
- 120 patients will be recruited from glaucoma clinics in SNEC
- Patients age ≥ 21 years old
- Patients who require trabeculectomy operation
Treatment of subjects
Study Procedures:
- Fluorescein staining will be used to visualize patient eyes.
- Schirmer's test will be used to measure the amount of tear production
- A small strip of filter paper will be inserted inside the lower eyelid
- A topical aneasthetic is placed into the eye before the filter paper to prevent tearing due to the irritation from the paper
- The eyes are closed for 5 minutes.
- The paper is then removed and the amount of moisture is measured
- Impression cytology will be performed to collect the superficial conjunctival cells for analysis
- While the eye is still anaesthetized from Schirmer's test, one end of a filter paper will be impressed upon the temporal conjunctiva whilst the other hand is grasped in place with a blunt smooth edged forceps.
- The filter paper is removed from the conjunctiva with a peeling motion after 2-3 seconds.
- The paper is placed into an eppendorf tube for future analysis.
- Tear osmolarity, Tear Break Up Time (TBUT) will be measured in all patients
- Tear osmolarity will be measured using the osmolarity chip, 3 chips per eye
- Anterior segment optical coherence tomography will be performed to assess the tear meniscus and image for any conjunctivochalasis
- The patient will be asked to look at a target in the instrument while blinking normally. The instrument will scan the lower eyelid margin for imaging of the tear meniscus and conjunctivochalasis
- Symptoms and severity of dry eye disease will be assessed through the Visual Analog Scale (VAS) system
Assessment of efficacy Outcome Measures
- Symptoms and severity of dry eye disease will be quantified based on the Visual Analog Scale (VAS)11
- Amount of moisture of the filter paper will be measured in Schirmer's test
- Clinical assessment of dry eye disease through Tear break up time (TBUT) and Tear Osmolarity measurements
- Tear meniscus height and area in the images obtained with optical coherence tomography
Target sample size 120 subjects will be enrolled in the study.
- Conditions
- Glaucoma
- Keywords
- Tear proteins profiles, Longitudinal, Ocular surface damage, Trabeculectomy
- Medical subject headings
- Glaucoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the tear protein profiles in trabeculectomy patients at 3 years
Measured: Baseline and 3 years
Secondary outcomes (4)
Symptoms and severity of dry eye disease
Measured: Baseline and 3 years
Amount of tears will be measured
Measured: Baseline and 3 years
Tear Osmolarity will be measured
Measured: Baseline and 3 years
Tear meniscus height will be measured
Measured: Baseline and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Louis Tong, Singapore National Eye Centre
- Investigators
- Louis Tong, PhD, Principal investigator, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841580
- Sponsor's protocol ID
- R980/89/2012
- Other IDs
- 2013/020/A
- Status last verified
- Oct 2018
- First submitted
- 19 Apr 2013
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Observation of Tear Proteomic Profiles and Ocular Surface in Trabeculectomy Patients Before and After Surgery
- ClinicalTrials.gov ID
- NCT01841580
- Acronym / sponsor ID
- R980/89/2012
- Conditions
- Glaucoma
- Keywords
- Tear proteins profiles, Longitudinal, Ocular surface damage, Trabeculectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- Nov 2013
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 70 million people world-wide are affected with glaucoma, of whom 6.7 million have bilateral blindness.5 Elevated intro-ocular pressure is the major modifiable risk factor in glaucoma, and reducing intraocular pressure to a consistently low level can delay disease progression and therefore, blindness.6 Topical intraocular pressure -lowering medication remains the first-line treatment for glaucoma, with surgical intervention playing a secondary role in cases suboptimally controlled with medication alone.
In this study, we plan to assess the change in tear proteins in trabeculectomy patients before and after operations. It is hoped that this study could help us gain more understanding of the possible mechanism accounting for the development of dry eye disease in glaucoma patients, which could help us develop better screening modalities and therapeutic agents for glaucoma patients at risk to prevent the development of dry eye disease.
Detailed description
Study Objectives and Purpose
There are two primary aims in this study:
- To assess changes in the tear proteomic profiles in pre-trabeculectomy and post-trabeculectomy patients
- To assess the changes in clinical signs of the eye and tear film as well as dry eye symptoms.
Study Material Human Tears will be collected from patients in SNEC clinic
Study Design:
120 patients will be recruited for this study (details as described below). Schirmers I test, Tear Osmolarity, Tear Break Up Time (TBUT), Anterior segment optical coherence tomography (ASOCT) and Impression cytology will be done during the study visits. Subjective symptom and severity of dry eye disease will be assessed through Visual Analog Scale (VAS).
No. of visits:
There will be 4 visits in this study. Visit 1: Pre-trabeculectomy operation Visit 2: 6 month after trabeculectomy surgery Visit 3: 1 year after trabeculectomy surgery Visit 4: 3 years after trabeculectomy surgery
Selection and Withdrawal of Subjects Recruitment Criteria
- 120 patients will be recruited from glaucoma clinics in SNEC
- Patients age ≥ 21 years old
- Patients who require trabeculectomy operation
Treatment of subjects
Study Procedures:
- Fluorescein staining will be used to visualize patient eyes.
- Schirmer's test will be used to measure the amount of tear production
- A small strip of filter paper will be inserted inside the lower eyelid
- A topical aneasthetic is placed into the eye before the filter paper to prevent tearing due to the irritation from the paper
- The eyes are closed for 5 minutes.
- The paper is then removed and the amount of moisture is measured
- Impression cytology will be performed to collect the superficial conjunctival cells for analysis
- While the eye is still anaesthetized from Schirmer's test, one end of a filter paper will be impressed upon the temporal conjunctiva whilst the other hand is grasped in place with a blunt smooth edged forceps.
- The filter paper is removed from the conjunctiva with a peeling motion after 2-3 seconds.
- The paper is placed into an eppendorf tube for future analysis.
- Tear osmolarity, Tear Break Up Time (TBUT) will be measured in all patients
- Tear osmolarity will be measured using the osmolarity chip, 3 chips per eye
- Anterior segment optical coherence tomography will be performed to assess the tear meniscus and image for any conjunctivochalasis
- The patient will be asked to look at a target in the instrument while blinking normally. The instrument will scan the lower eyelid margin for imaging of the tear meniscus and conjunctivochalasis
- Symptoms and severity of dry eye disease will be assessed through the Visual Analog Scale (VAS) system
Assessment of efficacy Outcome Measures
- Symptoms and severity of dry eye disease will be quantified based on the Visual Analog Scale (VAS)11
- Amount of moisture of the filter paper will be measured in Schirmer's test
- Clinical assessment of dry eye disease through Tear break up time (TBUT) and Tear Osmolarity measurements
- Tear meniscus height and area in the images obtained with optical coherence tomography
Target sample size 120 subjects will be enrolled in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 120 patients will be recruited for this study
Key inclusion criteria (3 listed)
- 120 patients will be recruited from glaucoma clinics in SNEC
- Patients age ≥ 21 years old
- Patients who require trabeculectomy operation
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in the tear protein profiles in trabeculectomy patients at 3 years
Time frame: Baseline and 3 years
4 secondary outcomes
Symptoms and severity of dry eye disease
Time frame: Baseline and 3 years
Amount of tears will be measured
Time frame: Baseline and 3 years
Tear Osmolarity will be measured
Time frame: Baseline and 3 years
Tear meniscus height will be measured
Time frame: Baseline and 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Tong, PhD principal investigator
Singapore National Eye Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Singapore National Eye Centre at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the tear protein profiles in trabeculectomy patients at 3 years (time frame: Baseline and 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018; AzTrials last refreshed its copy on 29 Oct 2026.