Glaucoma, Angle-ClosureNCT03159780
Prevalence of Corneal Astigmatism Before Glaucoma Surgery in Chinese Patients With Primary Angle-closure Glaucoma
An observational study of Glaucoma, Angle-Closure and Astigmatism, run by Mingkai Lin at 1 site in China.
Trial summary
Clear-lens extraction has been considered as first-line therapy for primary angle closure glaucoma(PACG) and application of toric intraocular lens (IOLs) leads to better postoperative visual acuity, yet little is known about the prevalence of corneal astigmatism in PACG patients. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Glaucoma, Angle-Closure, Astigmatism
- How many people
- 808 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Aug 2017
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary angle closure was defi ned as iridotrabecular contact, either appositional or synechial, of at least 180° on gonioscopy, and primary angle-closure glaucoma as reproducible glaucomatous visual fi eld defects, glaucomatous optic neuropathy, or both, and intraocular pressure greater than 21 mm Hg on at least one occasion.
Who may be able to join
- Patients who are phakic and aged 40 years or older , and had newly diagnosed primary angle closure with intraocular pressure 30 mm Hg or greater or primary angle-closure glaucoma, will be recruited during preoperative screening at Zhongshan Ophthalmic Center.
Who cannot join
- Patients with corneal disease, irregular astigmatism, previous corneal or intraocular surgery, or a history of ocular inflammation will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Clear-lens extraction has been considered as first-line therapy for primary angle closure glaucoma(PACG) and application of toric intraocular lens (IOLs) leads to better postoperative visual acuity, yet little is known about the prevalence of corneal astigmatism in PACG patients. We intend to make biometry examination for Chinese PACG patients, to obtain keratometry (K) , axial length (AL) and so on, and demographics data will also be recorded. We will study the prevalence of corneal astigmatism before glaucoma surgery in Chinese patients with PACG. Furthermore, differences of corneal astigmatism between primary angle-closure glaucoma and cataract patients will be explored. Finally, the prevalence of corneal astigmatism before glaucoma surgery in Chinese patients with PACG will be portrayed and can be instructive to the IOLs' manufactering.
Read the detailed description
Biometry examination contains keratometry (K) , axial length (AL), central anterior chamber depth, visual field loss(mean deviation, MD), choroidal thickness(CT), range of goniosynechia, and stage of PACG.
Demographics data contains age, gender, and eye.
- Conditions
- Glaucoma, Angle-Closure, Astigmatism
- Medical subject headings
- Glaucoma, Angle-Closure, Astigmatism
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of corneal astigmatism
Data of corneal astigmatism will be acquired through examination,and different types of corneal astigmatism will be diagnosed and seperated.Moreover,we will analyse the prevalence of corneal astigmatism,and compare among different age groups and different genders.Correlation between demographic features and data will be analysed,too.
Measured: During preoperative screening (1 day)
Secondary outcomes (2)
Prevalence of keratometry
Flat,steep and mean keratometry will be examined before glaucoma surgery. Moreover,we will analyse the prevalence of corneal astigmatism,and compare among different age groups and different genders.
Measured: During preoperative screening (1 day)
Prevalence of axial length
Axial length will be measured by both IOL Master and A-scan, and data will be compared between different measurements,different genders and different age groups.
Measured: During preoperative screening (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start1 Jan 2017
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 808 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mingkai Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mingkai Lin, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Mingkai Lin, MD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159780
- Sponsor's protocol ID
- ZhongshanOC20170503
- Status last verified
- Oct 2017
- First submitted
- 17 May 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Azuara-Blanco A, Burr J, Ramsay C, Cooper D, Foster PJ, Friedman DS, Scotland G, Javanbakht M, Cochrane C, Norrie J; EAGLE study group. Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE): a randomised controlled trial. Lancet. 2016 Oct 1;388(10052):1389-1397. doi: 10.1016/S0140-6736(16)30956-4.
PubMed 27707497Gao X, Huang W, Wang W, Zhou M, Wang J, Du S, Chen S, Zhang X. Topographic profile of choroid in eyes after acute primary angle-closure. Can J Ophthalmol. 2016 Oct;51(5):354-361. doi: 10.1016/j.jcjo.2016.02.025. Epub 2016 Sep 3.
PubMed 27769326Chen W, Zuo C, Chen C, Su J, Luo L, Congdon N, Liu Y. Prevalence of corneal astigmatism before cataract surgery in Chinese patients. J Cataract Refract Surg. 2013 Feb;39(2):188-92. doi: 10.1016/j.jcrs.2012.08.060. Epub 2012 Nov 7.
PubMed 23141077Zuo C, Gong R, Chen W, Chen C, Su J, Wei K, Gao X, Lin M, Ge J. Investigation of Corneal Astigmatism in Chinese Patients With Primary Angle Closure Disease. J Glaucoma. 2018 Dec;27(12):1131-1135. doi: 10.1097/IJG.0000000000001061.
PubMed 30134368
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Corneal Astigmatism Before Glaucoma Surgery in Chinese Patients With Primary Angle-closure Glaucoma
- ClinicalTrials.gov ID
- NCT03159780
- Acronym / sponsor ID
- ZhongshanOC20170503
- Conditions
- Glaucoma, Angle-Closure, Astigmatism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 808 participants (actual)
- Lead sponsor
- Mingkai LinUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 19 May 2017 (actual)
- 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.
Clear-lens extraction has been considered as first-line therapy for primary angle closure glaucoma(PACG) and application of toric intraocular lens (IOLs) leads to better postoperative visual acuity, yet little is known about the prevalence of corneal astigmatism in PACG patients. We intend to make biometry examination for Chinese PACG patients, to obtain keratometry (K) , axial length (AL) and so on, and demographics data will also be recorded. We will study the prevalence of corneal astigmatism before glaucoma surgery in Chinese patients with PACG. Furthermore, differences of corneal astigmatism between primary angle-closure glaucoma and cataract patients will be explored. Finally, the prevalence of corneal astigmatism before glaucoma surgery in Chinese patients with PACG will be portrayed and can be instructive to the IOLs' manufactering.
Detailed description
Biometry examination contains keratometry (K) , axial length (AL), central anterior chamber depth, visual field loss(mean deviation, MD), choroidal thickness(CT), range of goniosynechia, and stage of PACG.
Demographics data contains age, gender, and eye.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary angle closure was defi ned as iridotrabecular contact, either appositional or synechial, of at least 180° on gonioscopy, and primary angle-closure glaucoma as reproducible glaucomatous visual fi eld defects, glaucomatous optic neuropathy, or both, and intraocular pressure greater than 21 mm Hg on at least one occasion.
Key inclusion criteria (1 listed)
- Patients who are phakic and aged 40 years or older , and had newly diagnosed primary angle closure with intraocular pressure 30 mm Hg or greater or primary angle-closure glaucoma, will be recruited during preoperative screening at Zhongshan Ophthalmic Center.
Key exclusion criteria (1 listed)
- Patients with corneal disease, irregular astigmatism, previous corneal or intraocular surgery, or a history of ocular inflammation will be excluded.
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
Prevalence of corneal astigmatism
Time frame: During preoperative screening (1 day)
Data of corneal astigmatism will be acquired through examination,and different types of corneal astigmatism will be diagnosed and seperated.Moreover,we will analyse the prevalence of corneal astigmatism,and compare among different age groups and different genders.Correlation between demographic features and data will be analysed,too.
2 secondary outcomes
Prevalence of keratometry
Time frame: During preoperative screening (1 day)
Prevalence of axial length
Time frame: During preoperative screening (1 day)
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 2017.
- Results publication: PubMed 27707497Azuara-Blanco A, Burr J, Ramsay C, Cooper D, Foster PJ, Friedman DS, Scotland G, Javanbakht M, Cochrane C, Norrie J; EAGLE study group. Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE): a randomised controlled trial. Lancet. 2016 Oct 1;388(10052):1389-1397. doi: 10.1016/S0140-6736(16)30956-4.
- Results publication: PubMed 27769326Gao X, Huang W, Wang W, Zhou M, Wang J, Du S, Chen S, Zhang X. Topographic profile of choroid in eyes after acute primary angle-closure. Can J Ophthalmol. 2016 Oct;51(5):354-361. doi: 10.1016/j.jcjo.2016.02.025. Epub 2016 Sep 3.
- Results publication: PubMed 23141077Chen W, Zuo C, Chen C, Su J, Luo L, Congdon N, Liu Y. Prevalence of corneal astigmatism before cataract surgery in Chinese patients. J Cataract Refract Surg. 2013 Feb;39(2):188-92. doi: 10.1016/j.jcrs.2012.08.060. Epub 2012 Nov 7.
- Derived from this study: PubMed 30134368Zuo C, Gong R, Chen W, Chen C, Su J, Wei K, Gao X, Lin M, Ge J. Investigation of Corneal Astigmatism in Chinese Patients With Primary Angle Closure Disease. J Glaucoma. 2018 Dec;27(12):1131-1135. doi: 10.1097/IJG.0000000000001061.
- Individual participant dataSharing planned: Undecided
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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.
Mingkai Lin, MD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
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 and Astigmatism, run by Mingkai Lin at 1 site in China.
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 31 Oct 2017. 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 China. 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?
Prevalence of corneal astigmatism (time frame: During preoperative screening (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03159780, which also lists 4 linked publications.
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 2017.