Glaucoma, Angle-ClosureNCT02054403
Angle Closure (Glaucoma) in Caucasians
An observational study of Glaucoma, Angle-Closure, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Primary angle closure glaucoma (PACG) causes high rates of blindness, either by means of a painful attack of acute angle closure glaucoma or unnoticed over a period of many years. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Angle-Closure
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2014to Oct 2015
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will consist of Caucasian patients, aged 40-80 years. Patients will be recruited at the University Eye Clinic Maastricht, the Netherlands. All study participants are derived from the study 'Caucasian patients with angle closure on SS-OCT', METC 13-4-108.
Who may be able to join
- Caucasian race
- 40-80 years
- Willing and able to comply with scheduled visits and other study procedures
- Signed informed consent
- Participants derived from the study 'Caucasian patients with angle closure on SS-OCT' AND 1 or more of the following:
- Irido-trabecular contact (ITC) in ≥2 quadrants as seen with SS-OCT in darkened conditions
- Scleral spur angle (SSA) <20˚ (in 0 and 180º) AND anterior chamber depth (ACD) < 2.5 mm as seen with SS-OCT in darkened conditions
- The fellow, non-treated eye in a patient after an acute primary angle closure (APAC) attack in the other eye. APAC is defined as an abrupt onset of symptomatic elevation of IOP resulting from total closure of the angle which is typically not self-limiting (although acute attacks can rarely resolve spontaneously).
Who cannot join
- Any condition including (previous) intraocular laser/incisional surgery or medical procedure or treatment in ophthalmology
- Any eye condition/abnormality that will affect the acquisition/reliability of measurement (results), (e.g. vitreous haemorrhage, uveitis, intraocular trauma, significant corneal opacity)
- Unable to communicate properly or to understand instructions
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Eye Clinic Maastricht
Maastricht, 6202AZ
Carroll AB Webers, MD, PhD, FEBOpht, +31 43 3875346, c.webers@mumc.nl
Hellen CS Römkens, MD, +31 43 3871779, hellen.romkens@mumc.nl
About this study
Official title: Structural and Functional Parameters in Caucasian Patients With Angle Closure on SS-OCT
Rationale: Primary angle closure glaucoma (PACG) causes high rates of blindness, either by means of a painful attack of acute angle closure glaucoma or unnoticed over a period of many years. Patients with angle closure are particularly at risk but can be detected during an ophthalmological examination and sent for early preventive (laser) intervention. Current practice shows that patients at risk of PACG are frequently missed during routine examinations. Moreover, new imaging techniques like swept source optical coherence tomography (SS-OCT), are emerging with which the angle of the anterior chamber can be imaged in great detail with no burden for the patient. These techniques are already used in clinical practice and replace and complete part of the ophthalmic examination. However, in Caucasians, it is not yet known to what extent angle closure is detected in regular care and can be detected with this OCT device. There are few published data concerning angle closure and PACG in Caucasians and its characteristics.
Objective: To quantify the presence of angle closure by gonioscopy in patients at risk of angle closure on SS-OCT. Secondary objectives are to quantify the presence of an increased intra-ocular pressure during the day or after dark provocation, to quantify morphometric details of the anterior chamber, structural changes, and corneal endothelial cells and to quantify the functional changes of the visual field.
Read more
Study design: prospective, observational, descriptive study. Study population: Caucasian patients, presenting at the outpatient clinic of the University Eye Clinic Maastricht, aged 40 to 80 years, who are diagnosed with angle closure on SS-OCT.
Intervention (if applicable): Not applicable. Main study parameters/endpoints: The main study parameter is assessment of the anterior chamber angle according to gonioscopy. Secondary study parameters are the presence of an increased intra-ocular pressure (IOP) (>21 mmHg) during the day or after dark provocation (IOP rise from baseline), morphometric details of the anterior chamber, structural changes of the retinal nerve fiber layer, number of corneal endothelial cells and functional changes of the visual field Hypothesis: It is hypothesised that, based on its resolution and ease of use, SS-OCT is a suitable imaging technique to identify patients with or at risk of angle closure. It will be of value as an additional diagnostic instrument and may even replace gonioscopy.
- Conditions
- Glaucoma, Angle-Closure
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| angle closure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle closure on gonioscopy
The percentage of subjects with angle closure on gonioscopy compared with angle closure on SS-OCT.
Measured: 3 weeks
Secondary outcomes (1)
intra-ocular pressure (IOP)
The secondary outcome measure is the percentage of patients with presence of an increased intra-ocular pressure (>21 mmHg) during the day or after dark provocation (IOP rise from baseline)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Angle-ClosureStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054403
- Sponsor's protocol ID
- NL47347.068.13/METC 13-2-060
- Status last verified
- Feb 2014
- First submitted
- 30 Jan 2014
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Parameters in Caucasian Patients With Angle Closure on SS-OCT
- ClinicalTrials.gov ID
- NCT02054403
- Acronym / sponsor ID
- NL47347.068.13/METC 13-2-060
- Conditions
- Glaucoma, Angle-Closure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 4 Feb 2014 (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.
Rationale: Primary angle closure glaucoma (PACG) causes high rates of blindness, either by means of a painful attack of acute angle closure glaucoma or unnoticed over a period of many years. Patients with angle closure are particularly at risk but can be detected during an ophthalmological examination and sent for early preventive (laser) intervention. Current practice shows that patients at risk of PACG are frequently missed during routine examinations. Moreover, new imaging techniques like swept source optical coherence tomography (SS-OCT), are emerging with which the angle of the anterior chamber can be imaged in great detail with no burden for the patient. These techniques are already used in clinical practice and replace and complete part of the ophthalmic examination. However, in Caucasians, it is not yet known to what extent angle closure is detected in regular care and can be detected with this OCT device. There are few published data concerning angle closure and PACG in Caucasians and its characteristics.
Objective: To quantify the presence of angle closure by gonioscopy in patients at risk of angle closure on SS-OCT. Secondary objectives are to quantify the presence of an increased intra-ocular pressure during the day or after dark provocation, to quantify morphometric details of the anterior chamber, structural changes, and corneal endothelial cells and to quantify the functional changes of the visual field.
Study design: prospective, observational, descriptive study. Study population: Caucasian patients, presenting at the outpatient clinic of the University Eye Clinic Maastricht, aged 40 to 80 years, who are diagnosed with angle closure on SS-OCT.
Intervention (if applicable): Not applicable. Main study parameters/endpoints: The main study parameter is assessment of the anterior chamber angle according to gonioscopy. Secondary study parameters are the presence of an increased intra-ocular pressure (IOP) (>21 mmHg) during the day or after dark provocation (IOP rise from baseline), morphometric details of the anterior chamber, structural changes of the retinal nerve fiber layer, number of corneal endothelial cells and functional changes of the visual field Hypothesis: It is hypothesised that, based on its resolution and ease of use, SS-OCT is a suitable imaging technique to identify patients with or at risk of angle closure. It will be of value as an additional diagnostic instrument and may even replace gonioscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| angle closure | – | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will consist of Caucasian patients, aged 40-80 years. Patients will be recruited at the University Eye Clinic Maastricht, the Netherlands. All study participants are derived from the study 'Caucasian patients with angle closure on SS-OCT', METC 13-4-108.
Key inclusion criteria (8 listed)
- Caucasian race
- 40-80 years
- Willing and able to comply with scheduled visits and other study procedures
- Signed informed consent
- Participants derived from the study 'Caucasian patients with angle closure on SS-OCT' AND 1 or more of the following:
Key exclusion criteria (3 listed)
- Any condition including (previous) intraocular laser/incisional surgery or medical procedure or treatment in ophthalmology
- Any eye condition/abnormality that will affect the acquisition/reliability of measurement (results), (e.g. vitreous haemorrhage, uveitis, intraocular trauma, significant corneal opacity)
- Unable to communicate properly or to understand instructions
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
Angle closure on gonioscopy
Time frame: 3 weeks
The percentage of subjects with angle closure on gonioscopy compared with angle closure on SS-OCT.
1 secondary outcome
intra-ocular pressure (IOP)
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
Related trials for Glaucoma, Angle-Closure
Not yet recruiting
Combined Phacoemulsification-Goniotomy in Primary Open-Angle and Primary Angle-Closure Glaucoma
Primary Open-Angle Glaucoma, Primary Angle-Closure Glaucoma
RecruitingObservational study
Dresden Glaucoma and Treatment Study (DGTS)
Glaucoma, Glaucoma, Open-Angle
Not yet recruiting
Testing a Reading Module to Improve Reading Skills and Quality of Life in Glaucoma Patients
Primary Open Angle Glaucoma (POAG), Juvenile Open Angle Glaucoma
Not yet recruitingObservational study
Predicting the Risk of Partial Ciliary Block After Cataract and Goniosynechialysis Surgery in Primary Angle-Closure Disease
Primary Angle-Closure Glaucoma
Active, not recruiting
Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery
Glaucoma, Open-Angle, Glaucoma, Narrow Angle
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.
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, Angle-Closure, run by Maastricht University Medical Center at 1 site in Netherlands.
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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Feb 2014. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carroll AB Webers, MD, PhD, FEBOpht (+31 43 3875346, c.webers@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angle closure on gonioscopy (time frame: 3 weeks). 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 4 Feb 2014.