Macular Pigment Optical Density in Primary Angle-closure Disease

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

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Glaucoma, Angle-Closure; Macular Pigment Optical Density
• Intervention / Treatment: Other: Ocular examination

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Zhihong Huang, M.D; Phone Number: 02066615461 +8602066615461; Email: 575772588@qq.com
• Study Contact Backup: Name: Chengguo Zuo, M.D,Ph.D; Phone Number: 02066615461 +8602066615461; Email: chengguozuo@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhognshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Zhihong O Huang; Phone Number: 02066615461 +8602066615461; Email: 575772588@qq.com
      • Contact: Chengguo O Zuo; Phone Number: 02066615461 +8602066615461; Email: chengguozuo@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Outpatients >=40 years old PACD

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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
Matched Eyes; Healthy population matched by sex and age.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Mean outer retinal thickness	Outer retinal (OR) thickness was calculated by subtracting GCC thickness from CRT.	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	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Use Snellen visual acuity chart to measure naked eye vision and best corrected vision	3 months after surgery
Intraocular pressure	Using non-contact tonometer (NCT) measuring intraocular pressure	3 months after surgery
Cup/ Disk ( C/ D）	determine the cup to disc ratio by ophthalmoscope	3 months after surgery

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Investigators: Study Director: Chengguo Zuo, Zhognshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2021
• Primary Completion (ANTICIPATED): March 30, 2024
• Study Completion (ANTICIPATED): December 30, 2024

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (ACTUAL): February 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Glaucoma, Angle-Closure; Macular Pigment Optical Density; PACD-Primary Angle Closure Disease
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Angle-Closure
• Other Study ID Numbers: 2020KYPJ82

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) needed to be keep security.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No