GlaucomaNCT05251792
Macular Pigment Optical Density in Primary Angle-closure Disease
An observational study of Glaucoma and Glaucoma, Angle-Closure, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
Glaucoma is the leading cause of irreversible blindness in the world, and primary angle-closure glaucoma (PACG) is the most important type of glaucoma in Asia. Primary angle closure disease (PACD) is a group of diseases related to PACG, and the pathogenesis is still unclear. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Glaucoma, Angle-Closure, Macular Pigment Optical Density
- What is being tested?
- Ocular examination
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2021to 30 Dec 2024
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients >=40 years old PACD
Who may be able to join
- Experimental group：
- (1) According to the diagnostic criteria of PACD
- (2)History of peripheral iridectomy or trabeculectomy
- (3)Over 40
- (4)Phakic eyes
- (5)Intraocular pressure is less than 21mmhg, more than one week
Show all 12Show fewer
- (6)Eyes with clear optical media.
- Control group：
- (1)No history of glaucoma and other eye diseases
- (2)Phakic eyes
- (3)Over 40
- (4)Intraocular pressure10~21mmHg
Who cannot join
- (1)History of corneal diseases
- (2)History of eye tumor or other ophthalmic surgery
- (3)Cataract
- (4)Taking supplements containing lutein within 6 months
- (5)Snellen's visual acuity was less than 6 / 20，the diopter is beyond ± 6 degrees
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Zhihong O Huang, +8602066615461 ext. 02066615461, 575772588@qq.com
Chengguo O Zuo, +8602066615461 ext. 02066615461, chengguozuo@163.com
About this study
Official title: Study on the Relationship Between Macular Pigment Optical Density and Primary Angle-closure Disease
Glaucoma is the leading cause of irreversible blindness in the world, and primary angle-closure glaucoma (PACG) is the most important type of glaucoma in Asia. Primary angle closure disease (PACD) is a group of diseases related to PACG, and the pathogenesis is still unclear. Macular pigment has the functions of filtering short-wavelength waves and anti-oxidation, which are related to visual function. Previous studies have found that the macular pigment density (MPOD) is significantly reduced in primary open-angle glaucoma. This project uses the single-wavelength reflection method to measure MPOD, observes the characteristics of PACD and the normal control group's changes in retinal MPOD, and explains the relationship between PACD's MPOD changes and angle-closure glaucoma optic nerve damage
Read the detailed description
Observation index： Visual acuity，Intraocular pressure，Ophthalmoscope，MPOD，Visual field and OCT.
Inspection parameters of OCT：
- Retinal nerve fiber layer thickness
- Ganglion cell complex thickness
- Mean thickness of the central retina
- Mean defect
- Being tested
- Ocular examination
- Keywords
- Glaucoma, Angle-Closure, PACD-Primary Angle Closure Disease, Macular Pigment Optical Density
- Medical subject headings
- Glaucoma, Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular examinationOther
All participants underwent a detailed examination, including visual acuity, slit lamp biomicroscopy, direct ophthalmoscopy, optometry noncontact tonometry,MPOD measurement and optical coherence tomography (OCT) measurement
| Study group | Role | What they receive |
|---|---|---|
| Primary Angle Clousure Diseases Eyes | Over 40 years old, regardless of gender. Patients diagnosed with PACD (PACG or PAC or PACS) with phakic eyes. Peripheral iridectomy or trabeculectomy, more than 3 months after operation. Receives: Other: Ocular examination | |
| Matched Eyes | Healthy population matched by sex and age. Receives: Other: Ocular examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Pigment Optical Density（MPOD）Measurement
A one-wavelength fundus reflectance method (Visucam 200; Carl Zeiss Meditec) was used for the detection of MPOD as previously described. The right or left eye was randomly selected for measurement. The parameters and profiles of MPOD in a 7-degree eccentricity that corresponded to a 4 mm diameter were evaluated and output. Parameters included max and mean optical density (OD), volume, and area. MaxOD and MeanOD with units "d.u." (initial of density units) were used for the analyses.
Measured: 3 months after surgery
Retinal nerve fiber layer thickness
Detection by optical coherence tomography (OCT). Circumpapillary RNFL scans were obtained using the standard 3.4 mm 12-degree circumpapillary nerve fiber layer scan protocol.We recorded superior, inferior, nasal, temporal, and total RNFL thickness.
Measured: 3 months after surgery
Ganglion cell complex (GCC)thickness
Detection by optical coherence tomography (OCT). The distance from the internal limiting membrane and outer edge of the outer plexiform layer was defined as GCC thickness.
Measured: 3 months after surgery
Mean central retina thickness
Detection by optical coherence tomography (OCT). CRT thickness was defined as distance between the internal limiting membrane and the inner edge of the retinal pigment epithelium.
Measured: 3 months after surgery
Mean outer retinal thickness
Outer retinal (OR) thickness was calculated by subtracting GCC thickness from CRT.
Measured: 3 months after surgery
Visual Field Test
The visual field test uses the 30-2 Threshold Test on the Humphrey Visual Field Analyzer.According to the mean deviation (MD) values generated by the software, three groups of disease severity were classified: the mild group with MD > -6 dB, the moderate group with MD between -6 and -12 dB, and the severe group with MD < -12 dB
Measured: 3 months after surgery
Secondary outcomes (3)
Visual acuity
Use Snellen visual acuity chart to measure naked eye vision and best corrected vision
Measured: 3 months after surgery
Intraocular pressure
Using non-contact tonometer (NCT) measuring intraocular pressure
Measured: 3 months after surgery
Cup/ Disk ( C/ D）
determine the cup to disc ratio by ophthalmoscope
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start11 Nov 2021
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Dec 2024 (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.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chengguo Zuo, Study director, Zhognshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251792
- Sponsor's protocol ID
- 2020KYPJ82
- Status last verified
- Feb 2022
- First submitted
- 11 Feb 2022
- Last updated
- 13 Feb 2023
- 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 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Relationship Between Macular Pigment Optical Density and Primary Angle-closure Disease
- ClinicalTrials.gov ID
- NCT05251792
- Acronym / sponsor ID
- 2020KYPJ82
- Keywords
- Glaucoma, Angle-Closure, PACD-Primary Angle Closure Disease, Macular Pigment Optical Density
- 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
- 11 Nov 2021 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 23 Feb 2022 (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.
Glaucoma is the leading cause of irreversible blindness in the world, and primary angle-closure glaucoma (PACG) is the most important type of glaucoma in Asia. Primary angle closure disease (PACD) is a group of diseases related to PACG, and the pathogenesis is still unclear. Macular pigment has the functions of filtering short-wavelength waves and anti-oxidation, which are related to visual function. Previous studies have found that the macular pigment density (MPOD) is significantly reduced in primary open-angle glaucoma. This project uses the single-wavelength reflection method to measure MPOD, observes the characteristics of PACD and the normal control group's changes in retinal MPOD, and explains the relationship between PACD's MPOD changes and angle-closure glaucoma optic nerve damage
Detailed description
Observation index： Visual acuity，Intraocular pressure，Ophthalmoscope，MPOD，Visual field and OCT.
Inspection parameters of OCT：
- Retinal nerve fiber layer thickness
- Ganglion cell complex thickness
- Mean thickness of the central retina
- Mean defect
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Angle Clousure Diseases Eyes | – | Other: Ocular examinationOver 40 years old, regardless of gender. Patients diagnosed with PACD (PACG or PAC or PACS) with phakic eyes. Peripheral iridectomy or trabeculectomy, more than 3 months after operation. |
| Matched Eyes | – | Other: Ocular examinationHealthy population matched by sex and age. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients >=40 years old PACD
Key inclusion criteria (12 listed)
- Experimental group：
- (1) According to the diagnostic criteria of PACD
- (2)History of peripheral iridectomy or trabeculectomy
- (3)Over 40
- (4)Phakic eyes
Key exclusion criteria (5 listed)
- (1)History of corneal diseases
- (2)History of eye tumor or other ophthalmic surgery
- (3)Cataract
- (4)Taking supplements containing lutein within 6 months
- (5)Snellen's visual acuity was less than 6 / 20，the diopter is beyond ± 6 degrees
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocular examinationAll participants underwent a detailed examination, including visual acuity, slit lamp biomicroscopy, direct ophthalmoscopy, optometry noncontact tonometry,MPOD measurement and optical coherence tomography (OCT) measurement | Other | Matched Eyes, Primary Angle Clousure Diseases Eyes |
Primary outcome
Macular Pigment Optical Density（MPOD）Measurement
Time frame: 3 months after surgery
A one-wavelength fundus reflectance method (Visucam 200; Carl Zeiss Meditec) was used for the detection of MPOD as previously described. The right or left eye was randomly selected for measurement. The parameters and profiles of MPOD in a 7-degree eccentricity that corresponded to a 4 mm diameter were evaluated and output. Parameters included max and mean optical density (OD), volume, and area. MaxOD and MeanOD with units "d.u." (initial of density units) were used for the analyses.
Retinal nerve fiber layer thickness
Time frame: 3 months after surgery
Detection by optical coherence tomography (OCT). Circumpapillary RNFL scans were obtained using the standard 3.4 mm 12-degree circumpapillary nerve fiber layer scan protocol.We recorded superior, inferior, nasal, temporal, and total RNFL thickness.
Ganglion cell complex (GCC)thickness
Time frame: 3 months after surgery
Detection by optical coherence tomography (OCT). The distance from the internal limiting membrane and outer edge of the outer plexiform layer was defined as GCC thickness.
Mean central retina thickness
Time frame: 3 months after surgery
Detection by optical coherence tomography (OCT). CRT thickness was defined as distance between the internal limiting membrane and the inner edge of the retinal pigment epithelium.
Mean outer retinal thickness
Time frame: 3 months after surgery
Outer retinal (OR) thickness was calculated by subtracting GCC thickness from CRT.
Visual Field Test
Time frame: 3 months after surgery
The visual field test uses the 30-2 Threshold Test on the Humphrey Visual Field Analyzer.According to the mean deviation (MD) values generated by the software, three groups of disease severity were classified: the mild group with MD > -6 dB, the moderate group with MD between -6 and -12 dB, and the severe group with MD < -12 dB
3 secondary outcomes
Visual acuity
Time frame: 3 months after surgery
Intraocular pressure
Time frame: 3 months after surgery
Cup/ Disk ( C/ D）
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No. Individual participant data (IPD) needed to be keep security.
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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.
Chengguo 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 Glaucoma, Angle-Closure, 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?
The sponsor lists 12 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. 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 Zhihong Huang, M.D (+8602066615461 ext. 02066615461, 575772588@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular Pigment Optical Density（MPOD）Measurement (time frame: 3 months after surgery). The study lists 6 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 13 Feb 2023.