Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321386
Status:
UNKNOWN
Last Update Posted:
2011-06-28
First Post:
2006-05-01
Brief Title:
Analysis of Clinical Profiles of Chinese Patients With Normal Tension Glaucoma
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Parameters for Disease Progression in Chinese Patients With Normal Tension Glaucoma
Status:
UNKNOWN
Status Verified Date:
2011-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To obtain demographic and baseline ophthalmic parameters such as Intraocular Pressure profiles disc morphological characteristics central corneal thickness peripapillary retinal nerve fibre layer thickness and its serial changes visual field changes severity of any medical associations-eg hypertension migraine strokes silent cerebral infarcts with non-invasive measurements in Chinese Patients with Normal Tension Glaucoma
Detailed Description:
This is a multi-centered non-interventional descriptive study The Declaration of Helsinki is followed All procedures will be conducted in accordance with the GCP guidelines
About 100 Consecutive NTG glaucoma patients will be included in this study NTG is defined as
1 Six median untreated intraocular pressure consistently less than 21 mm Hg with no more than 1 reading 23 mmHg or 24 mmHg and with no single measurement greater than 24 mm Hg
2 Open drainage angles on gonioscopy
3 Typical optic disc damage with glaucomatous cupping and loss of neuroretinal rim
4 Absence of any secondary cause for a glaucomatous optic neuropathy trauma steroids uveitis
5 Glaucomatous visual field defect compatible with glaucomatous optic neuropathy
Age and sex-matched normal control subjects and age sex severity-matched POAG control subjects will be recruited
Randomization not required as this will be a non-interventional descriptive study
A complete baseline ophthalmic assessment will be performed with Snellen visual acuity VA Best-corrected VA intraocular pressure IOP measurements slit lamp examination gonioscopy disc assessment and dilated fundal examination
These measurements were performed at recruitment and then at 36912 months after the intervention The details of some of these measurements were as follows
All IOP was measured with Goldmann applanation tonometry The median of 5 readings were taken Gonioscopy was carried out first using a Goldmann 2-mirror gonioscope The examination was carried out at the lowest level of illumination that permitted a view of the angle and at high magnification 16 to 25 A 1-mm light beam was reduced to a very narrow slit and was offset horizontally for assessing superior and inferior angles and vertically for nasal and temporal angles Care was taken to avoid light falling on the pupil during gonioscopy Slight tilting to gain a view over the convexity of the iris was permitted but further manipulation of the lens or redirection of gaze was avoided because of the possibility of exerting pressure on the cornea and artificially widening the angle The drainage angle was graded according to Shaffers convention in each quadrant The average angle width was calculated by adding the Shaffer grade in each quadrant and dividing by 4 Indentation gonioscopy using a Posner lens was also used to detect PAS and the number of clock hours of PAS was recorded All gonioscopy was performed by a single investigator for standardization
The vertical CDR was taken to be the longest vertical cup diameter divided by the longest vertical disc diameter Estimates were made to the nearest 005 The vertical disc diameter was examined All features of a glaucomatous optic neuropathy were noted
All subjects underwent static automated white-on-white threshold perimetry program 24- 2 SITA standard model 750 Humphrey Instruments Dublin CA and the first reliable VF was used in our analysis The global indices mean deviation MD and pattern standard deviation PSD were documented for all cases After finding the proportion of VF that is reliable the VF was then scored using the tested scoring algorithm developed for the Advanced Glaucoma Intervention Study AGIS
Minimal criteria for glaucomatous VF defect were as follows glaucoma hemifield test outside normal limits pattern standard deviation with a P value of 5 or a cluster of 3 points in the pattern deviation plot in a single hemifield superior or inferior with P value of 5 one of which must have a P value of 1 Any one of the preceding criteria if repeatable was considered sufficient evidence of a glaucomatous VF defect
Subjects will be verified by diurnal tension curve which was recorded no more than one year before inclusion in the present study
Systemic haemodynamics Systolic diastolic and mean blood pressures SBP DBP MAP were measured on the upper arm by an automated oscillometric device Pulse rate PR and blood oxygenation was automatically recorded from a finger pulse oximetric device HP-CMS patient monitor Hewlett Packard Palo Alto CA USA
Measurement of intraocular pressure IOP A Median of 3 readings for each subject with Goldmann applanation tonometer was used for each measurement of intraocular pressure
Fundus Photography and Optical Coherence Tomography OCT A baseline fundus photo will be performed for all participants A baseline OCT for retinal nerve fiber layer thickness and optic nerve head parameters will be determined Serial changes of these parameters will be correlated to VF indices
Dynamic Contour Tonometry DCT and Ocular Response Analyzer ORA will also be performed on these subjects
A history of the following systemic conditions was recorded systemic hypertension HT hypotension ischemic heart disease IHD arrhythmia diabetes mellitus DM hypercholesterolemia cerebral vascular accidents CVA migraine obstructive sleep apnea OSA sensorineural hearing loss and Raynauds phenomenon All diagnoses were obtained from the history and confirmed by the clinical management system of the Hong Kong Hospital Authority which is a computerized database connecting all public hospitals and clinics in Hong Kong
Systemic use of statins beta-blockers angiotensin-converting-enzyme-inhibitors ACEI calcium-channel-blockers aspirin and diuretics was also noted
About 100 Consecutive NTG glaucoma patients will be included in this study NTG is defined as
1 Six median untreated intraocular pressure consistently less than 21 mm Hg with no more than 1 reading 23 mmHg or 24 mmHg and with no single measurement greater than 24 mm Hg
2 Open drainage angles on gonioscopy
3 Typical optic disc damage with glaucomatous cupping and loss of neuroretinal rim
4 Absence of any secondary cause for a glaucomatous optic neuropathy trauma steroids uveitis
5 Glaucomatous visual field defect compatible with glaucomatous optic neuropathy
Age and sex-matched normal control subjects and age sex severity-matched POAG control subjects will be recruited
Randomization not required as this will be a non-interventional descriptive study
A complete baseline ophthalmic assessment will be performed with Snellen visual acuity VA Best-corrected VA intraocular pressure IOP measurements slit lamp examination gonioscopy disc assessment and dilated fundal examination
These measurements were performed at recruitment and then at 36912 months after the intervention The details of some of these measurements were as follows
All IOP was measured with Goldmann applanation tonometry The median of 5 readings were taken Gonioscopy was carried out first using a Goldmann 2-mirror gonioscope The examination was carried out at the lowest level of illumination that permitted a view of the angle and at high magnification 16 to 25 A 1-mm light beam was reduced to a very narrow slit and was offset horizontally for assessing superior and inferior angles and vertically for nasal and temporal angles Care was taken to avoid light falling on the pupil during gonioscopy Slight tilting to gain a view over the convexity of the iris was permitted but further manipulation of the lens or redirection of gaze was avoided because of the possibility of exerting pressure on the cornea and artificially widening the angle The drainage angle was graded according to Shaffers convention in each quadrant The average angle width was calculated by adding the Shaffer grade in each quadrant and dividing by 4 Indentation gonioscopy using a Posner lens was also used to detect PAS and the number of clock hours of PAS was recorded All gonioscopy was performed by a single investigator for standardization
The vertical CDR was taken to be the longest vertical cup diameter divided by the longest vertical disc diameter Estimates were made to the nearest 005 The vertical disc diameter was examined All features of a glaucomatous optic neuropathy were noted
All subjects underwent static automated white-on-white threshold perimetry program 24- 2 SITA standard model 750 Humphrey Instruments Dublin CA and the first reliable VF was used in our analysis The global indices mean deviation MD and pattern standard deviation PSD were documented for all cases After finding the proportion of VF that is reliable the VF was then scored using the tested scoring algorithm developed for the Advanced Glaucoma Intervention Study AGIS
Minimal criteria for glaucomatous VF defect were as follows glaucoma hemifield test outside normal limits pattern standard deviation with a P value of 5 or a cluster of 3 points in the pattern deviation plot in a single hemifield superior or inferior with P value of 5 one of which must have a P value of 1 Any one of the preceding criteria if repeatable was considered sufficient evidence of a glaucomatous VF defect
Subjects will be verified by diurnal tension curve which was recorded no more than one year before inclusion in the present study
Systemic haemodynamics Systolic diastolic and mean blood pressures SBP DBP MAP were measured on the upper arm by an automated oscillometric device Pulse rate PR and blood oxygenation was automatically recorded from a finger pulse oximetric device HP-CMS patient monitor Hewlett Packard Palo Alto CA USA
Measurement of intraocular pressure IOP A Median of 3 readings for each subject with Goldmann applanation tonometer was used for each measurement of intraocular pressure
Fundus Photography and Optical Coherence Tomography OCT A baseline fundus photo will be performed for all participants A baseline OCT for retinal nerve fiber layer thickness and optic nerve head parameters will be determined Serial changes of these parameters will be correlated to VF indices
Dynamic Contour Tonometry DCT and Ocular Response Analyzer ORA will also be performed on these subjects
A history of the following systemic conditions was recorded systemic hypertension HT hypotension ischemic heart disease IHD arrhythmia diabetes mellitus DM hypercholesterolemia cerebral vascular accidents CVA migraine obstructive sleep apnea OSA sensorineural hearing loss and Raynauds phenomenon All diagnoses were obtained from the history and confirmed by the clinical management system of the Hong Kong Hospital Authority which is a computerized database connecting all public hospitals and clinics in Hong Kong
Systemic use of statins beta-blockers angiotensin-converting-enzyme-inhibitors ACEI calcium-channel-blockers aspirin and diuretics was also noted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CRE-2005434 | None | None | None |