GlaucomaNCT00347191
Relationship Between Central Corneal Thickness and Intraocular Pressure Measures Instruments.
An observational study of Glaucoma and Glaucoma, Open Angle, run by Aston University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the relationship between intraocular pressure and central corneal thickness using various instruments in ocular hypertension, normal-tension glaucoma, primary open angle glaucoma, keratoconus and normal eyes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Glaucoma, Open Angle, Ocular Hypertension
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2006to Jun 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical diagnosis of glaucoma, open angle; ocular hypertension; glaucoma (low-tension); keratoconus and other healthy volunteers.
Who may be able to join
- Adults over the age of 18 years Clinical diagnosis of glaucoma, open angle; ocular hypertension; glaucoma (low-tension); keratoconus and other healthy volunteers.
Who cannot join
- Children under the age of 18 years Adults with learning disabilities Adults who are unconscious or severely ill Adults who have known terminal illness Adults in emergency situations Adults with dementia Prisoners Young offenders Those who could be considered to have a dependant relationship with the investigator (i.e. those in care homes or medical students) Other vulnerable groups
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Solihull Hospital
Birmingham, West Midlands, B91 2JL
About this study
Official title: Phase 4 Study Evaluating the Relationship Between Intraocular Pressure and Central Corneal Thickness Using Various Instruments in Ocular Hypertension, Normal-tension Glaucoma, Primary Open Angle Glaucoma, Keratoconus and Normal Eyes.
The purpose of this study is to evaluate the relationship between intraocular pressure and central corneal thickness using various instruments in ocular hypertension, normal-tension glaucoma, primary open angle glaucoma, keratoconus and normal eyes.
Read the detailed description
The purpose of this study is to evaluate the relationship between intraocular pressure and ultrasound pachymetry measured central corneal thickness using Goldman tonometry and PASCAL instruments.
Patient groups examined include:
ocular hypertensives normal-tension glaucoma primary open angle glaucoma keratoconus control normal eyes
- Conditions
- Glaucoma, Glaucoma, Open Angle, Ocular Hypertension, Keratoconus
- Keywords
- Corneal thickness, Intraocular pressure, Instrumentation, Glaucoma, Keratoconus
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Ocular Hypertension, Keratoconus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJan 2006
- Study completionJun 2006
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- Aston University
- Sponsor type
- University, hospital or other
- Investigators
- Sunil Shah, MD FRCOphth, Principal investigator, Birmingham and Midland Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347191
- Sponsor's protocol ID
- 2006IOP
- Status last verified
- Jun 2011
- First submitted
- 30 Jun 2006
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study Evaluating the Relationship Between Intraocular Pressure and Central Corneal Thickness Using Various Instruments in Ocular Hypertension, Normal-tension Glaucoma, Primary Open Angle Glaucoma, Keratoconus and Normal Eyes.
- ClinicalTrials.gov ID
- NCT00347191
- Acronym / sponsor ID
- 2006IOP
- Conditions
- Glaucoma, Glaucoma, Open Angle, Ocular Hypertension, Keratoconus
- Keywords
- Corneal thickness, Intraocular pressure, Instrumentation, Glaucoma, Keratoconus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- Aston UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Jun 2006 (actual)
- First posted
- 4 Jul 2006 (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.
The purpose of this study is to evaluate the relationship between intraocular pressure and central corneal thickness using various instruments in ocular hypertension, normal-tension glaucoma, primary open angle glaucoma, keratoconus and normal eyes.
Detailed description
The purpose of this study is to evaluate the relationship between intraocular pressure and ultrasound pachymetry measured central corneal thickness using Goldman tonometry and PASCAL instruments.
Patient groups examined include:
ocular hypertensives normal-tension glaucoma primary open angle glaucoma keratoconus control normal eyes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical diagnosis of glaucoma, open angle; ocular hypertension; glaucoma (low-tension); keratoconus and other healthy volunteers.
Key inclusion criteria (1 listed)
- Adults over the age of 18 years Clinical diagnosis of glaucoma, open angle; ocular hypertension; glaucoma (low-tension); keratoconus and other healthy volunteers.
Key exclusion criteria (1 listed)
- Children under the age of 18 years Adults with learning disabilities Adults who are unconscious or severely ill Adults who have known terminal illness Adults in emergency situations Adults with dementia Prisoners Young offenders Those who could be considered to have a dependant relationship with the investigator (i.e. those in care homes or medical students) Other vulnerable groups
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
Not reported in the source record.
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 23 Jun 2011.
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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.
Sunil Shah, MD FRCOphth principal investigator
Birmingham and Midland 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 and Glaucoma, Open Angle, run by Aston University at 1 site in United Kingdom.
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 1 inclusion and 1 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 23 Jun 2011. 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 United Kingdom. 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.
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 23 Jun 2011.