Macular Pigment Optical Density in Primary Angle-closure Disease

NCT05251792 | Unknown

• 1 other identifier: 2020KYPJ82
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

Glaucoma, Angle-Closure; PACD-Primary Angle Closure Disease; Macular Pigment Optical Density

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Visual acuity

  3 months after surgery

• Intraocular pressure

  3 months after surgery

• Cup/ Disk ( C/ D）

  3 months after surgery

Study Arms (2)

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

Matched Eyes

Healthy population matched by sex and age.

Other: Ocular examination

Interventions

Ocular examination OTHER

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; Primary Angle Clousure Diseases Eyes

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Outpatients \>=40 years old PACD

You may qualify if:

• 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

You may not qualify if:

• (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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Glaucoma; Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Chengguo Zuo

  Zhognshan Ophthalmic Center, Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Zhihong Huang, M.D

CONTACT

+8602066615461; 575772588@qq.com

Chengguo Zuo, M.D,Ph.D

CONTACT

+8602066615461; chengguozuo@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 23, 2022
• Study Start: November 11, 2021
• Primary Completion: March 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 13, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)