Angle Closure (Glaucoma) in Caucasians
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|ClinicalTrials.gov Identifier: NCT02054403|
Recruitment Status : Unknown
Verified February 2014 by Maastricht University Medical Center.
Recruitment status was: Not yet recruiting
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Structural and Functional Parameters in Caucasian Patients With Angle Closure on SS-OCT|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||October 2015|
- Angle closure on gonioscopy [ Time Frame: 3 weeks ]The percentage of subjects with angle closure on gonioscopy compared with angle closure on SS-OCT.
- intra-ocular pressure (IOP) [ Time Frame: 3 weeks ]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)
- Visual field loss [ Time Frame: 3 weeks ]The percentage of patients with visual field loss on the HFA visual field.
- Retinal nerve fiber layer thickness [ Time Frame: 3 weeks ]The mean RNFL thickness will be measured.
- Number of corneal endothelial cells [ Time Frame: 3 weeks ]The mean number of corneal endothelial cells will be measured
- Axial length [ Time Frame: 3 weeks ]The mean axial length will be measured.
- Anterior chamber angle parameters [ Time Frame: 3 weeks ]
Parameters analysed from SS-OCT images to determine the morphometric details of the anterior chamber will be measured and means will be calculated.
For example AOD500, AOD750, TISA500, TISA750, ARA500, ARA750,TIA500, TIA750, ACD, LV
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): NCT02054403
|Contact: Carroll AB Webers, MD, PhD, FEBOpht||+31 43 firstname.lastname@example.org|
|Contact: Hellen CS Römkens, MD||+31 43 email@example.com|