Macular Pigment Optical Density in Primary Angle-closure Disease

Glaucoma Clinical Trial

Official title:

Study on the Relationship Between Macular Pigment Optical Density and Primary Angle-closure Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05251792
• Other study ID #: 2020KYPJ82
• Status: Recruiting
• Start date: November 11, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2022
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Zhihong Huang, M.D
• Phone: +8602066615461
• Email: 575772588[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Description:

Observation index： Visual acuity，Intraocular pressure，Ophthalmoscope，MPOD，Visual field and OCT.

Inspection parameters of OCT：

1. Retinal nerve fiber layer thickness

2. Ganglion cell complex thickness

3. Mean thickness of the central retina

4. Mean defect

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

• (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

Exclusion Criteria:

• (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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Angle-Closure
• Macular Pigment Optical Density

Intervention

Other:
• Ocular examination
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

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months after surgery
Primary	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.	3 months after surgery
Primary	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.	3 months after surgery
Primary	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.	3 months after surgery
Primary	Mean outer retinal thickness	Outer retinal (OR) thickness was calculated by subtracting GCC thickness from CRT.	3 months after surgery
Primary	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	3 months after surgery
Secondary	Visual acuity	Use Snellen visual acuity chart to measure naked eye vision and best corrected vision	3 months after surgery
Secondary	Intraocular pressure	Using non-contact tonometer (NCT) measuring intraocular pressure	3 months after surgery
Secondary	Cup/ Disk ( C/ D)	determine the cup to disc ratio by ophthalmoscope	3 months after surgery