GlaucomaMGNCT04220879
Study on Intraocular Structural Parameters and Surgical Effect Before and After the Onset of Malignant Glaucoma
An observational study of Glaucoma and Malignant Glaucoma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
In this retrospective observational study, we collected intraocular structure parameters of malignant glaucoma and primary angle closure glaucoma. Anterior chamber depth (ACD) and width (ACW), lens vault (LV), ciliary process-ciliary process distance(CCD), trabecular-ciliary processes distance (TCPD), ciliary body max… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Malignant Glaucoma
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2019to 24 Nov 2020
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients >=18 years old with or without malignant glaucoma
Inclusion Criteria: (1) history of operation, (2) diagnosis of MG, and (3) eyes with clear optical media.
Exclusion Criteria:(1)hypertension or diabetes and (2) diagnosis of ocular fundus diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Dingqiao O Wang, 02066615461 ext. 02066615461, wangdingqiao@163.com
Chengguo O Zuo, 02066615461 ext. 02066615461, chengguozuo@163.com
About this study
In this retrospective observational study, we collected intraocular structure parameters of malignant glaucoma and primary angle closure glaucoma. Anterior chamber depth (ACD) and width (ACW), lens vault (LV), ciliary process-ciliary process distance(CCD), trabecular-ciliary processes distance (TCPD), ciliary body max thickness (CBMT), peripheral iris thickness (PIT), trabecular ciliary process angle (TCPA), and anterior vault (AV), were measured by ultrasound biomicroscopy. Other parameters measured by A-scan ultrasonography and optical coherence tomography. To analyze the high risk factors and the possible pathogenesis of the disease and discuss the long-term effect of different treatment methods.
Read the detailed description
Outcome Measures:
Anterior chamber depth (ACD) and width (ACW), lens vault (LV), ciliary process-ciliary process distance(CCD), trabecular-ciliary processes distance (TCPD), ciliary body max thickness (CBMT), peripheral iris thickness (PIT), trabecular ciliary process angle (TCPA), and anterior vault (AV), were measured by ultrasound biomicroscopy. Other parameters measured by A-scan ultrasonography and optical coherence tomography.
- Conditions
- Glaucoma, Malignant Glaucoma
- Keywords
- Malignant Glaucoma, Biometric Measurements
- Medical subject headings
- Glaucoma
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 |
|---|---|---|
| Malignant Glaucoma | To determine the biometric measurements. | |
| Fellow Eyes | To determine the biometric measurements. | |
| Matched Eyes | To determine the biometric measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trabecular ciliary process angle
TCPA is measured with its apex at the scleral spur, one arm along the posterior corneal surface, and another arm along the most anterior surface of the ciliary body
Measured: baseline
Choroidal vascularity parameter
Choroidal vascularity parameter is a vessel ratio measured by optical coherence tomographic images
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start25 Nov 2019
- Primary completion24 Aug 2020 (estimated)
- Study completion24 Nov 2020 (estimated)
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
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chengguo O Zuo, Study director, Zhognshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220879
- Sponsor's protocol ID
- 2019KYPJ148
- Acronym
- MG
- Status last verified
- Jan 2020
- First submitted
- 5 Jan 2020
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) needed to be keep security.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Intraocular Structural Parameters and Surgical Effect Before and After the Onset of Malignant Glaucoma
- ClinicalTrials.gov ID
- NCT04220879
- Acronym / sponsor ID
- MG / 2019KYPJ148
- Conditions
- Glaucoma, Malignant Glaucoma
- Keywords
- Malignant Glaucoma, Biometric Measurements
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 24 Aug 2020 (estimated)
- Study completion
- 24 Nov 2020 (estimated)
- First posted
- 7 Jan 2020 (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.
In this retrospective observational study, we collected intraocular structure parameters of malignant glaucoma and primary angle closure glaucoma. Anterior chamber depth (ACD) and width (ACW), lens vault (LV), ciliary process-ciliary process distance(CCD), trabecular-ciliary processes distance (TCPD), ciliary body max thickness (CBMT), peripheral iris thickness (PIT), trabecular ciliary process angle (TCPA), and anterior vault (AV), were measured by ultrasound biomicroscopy. Other parameters measured by A-scan ultrasonography and optical coherence tomography. To analyze the high risk factors and the possible pathogenesis of the disease and discuss the long-term effect of different treatment methods.
Detailed description
Outcome Measures:
Anterior chamber depth (ACD) and width (ACW), lens vault (LV), ciliary process-ciliary process distance(CCD), trabecular-ciliary processes distance (TCPD), ciliary body max thickness (CBMT), peripheral iris thickness (PIT), trabecular ciliary process angle (TCPA), and anterior vault (AV), were measured by ultrasound biomicroscopy. Other parameters measured by A-scan ultrasonography and optical coherence tomography.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Malignant Glaucoma | – | –To determine the biometric measurements. |
| Fellow Eyes | – | –To determine the biometric measurements. |
| Matched Eyes | – | –To determine the biometric measurements. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients >=18 years old with or without malignant glaucoma
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
Trabecular ciliary process angle
Time frame: baseline
TCPA is measured with its apex at the scleral spur, one arm along the posterior corneal surface, and another arm along the most anterior surface of the ciliary body
Choroidal vascularity parameter
Time frame: baseline
Choroidal vascularity parameter is a vessel ratio measured by optical coherence tomographic images
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: No. Individual participant data (IPD) needed to be keep security.
Related trials for Glaucoma
Recruiting
Timing of Glaucoma Drainage Device With Boston Keratoprosthesis
Corneal Transplantation, Glaucoma
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Not yet recruitingPhase 2
VGFTe-(HD)-OD-2566: Adjunctive Aflibercept Ahmed Glaucoma Valve (AAA) Study
Glaucoma
Recruiting
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
Glaucoma, Corneal Transplantation
RecruitingPhase 1/2
A Study About the Safety of ASP2767 and Whether it Helps People With Glaucoma-Related Optic Nerve Damage
Glaucoma
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.
Chengguo O Zuo study director
Zhognshan 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 and Malignant Glaucoma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University 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?
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 7 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dingqiao O Wang, M.D (020-66615461 ext. 02066615461, wangdingqiao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trabecular ciliary process angle (time frame: baseline). The study lists 2 primary outcomes in all. 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 7 Jan 2020.