ClinicalTrials.gg
Status unknownNCT05251792Updated Feb 13, 2023

Macular Pigment Optical Density in Primary Angle-closure Disease

An observational study in Glaucoma, Glaucoma, Angle-Closure and Macular Pigment Optical Density, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-13.

Primary conditionGlaucoma, Angle-ClosureRegistry: GlaucomaReclassifiedWhy we changed it
Registry
Glaucoma — the first condition term the registry derived for this study.
ClinicalTrials.gg
Glaucoma, Angle-Closure
Why
  1. The study's listed conditions name Glaucoma, Angle-Closure, a narrower term within Glaucoma.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
40 Years to 90 Years
Sex
All
01

Study 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

Read the 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
02

Conditions studied

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

Browse trials for

Keywords

  • Glaucoma, Angle-Closure
  • PACD-Primary Angle Closure Disease
  • Macular Pigment Optical Density
03

In context

Glaucoma, Angle-Closure Reclassified

91 studies on the registry are indexed under Glaucoma, Angle-Closure; 17 are open to participants now.

This study's planned enrollment of 60 is below the median of 225 across 32 observational studies indexed under Glaucoma, Angle-Closure.

Browse Glaucoma, Angle-Closure studies →

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.

Compared within Glaucoma, Angle-Closure, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Glaucoma. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Outpatients >=40 years old PACD

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherOcular 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months after surgery

  2. 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.

    Time frame: 3 months after surgery

  3. 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.

    Time frame: 3 months after surgery

  4. 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.

    Time frame: 3 months after surgery

  5. Mean outer retinal thickness

    Outer retinal (OR) thickness was calculated by subtracting GCC thickness from CRT.

    Time frame: 3 months after surgery

  6. 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

    Time frame: 3 months after surgery

Secondary outcomes

  1. Visual acuity

    Use Snellen visual acuity chart to measure naked eye vision and best corrected vision

    Time frame: 3 months after surgery

  2. Intraocular pressure

    Using non-contact tonometer (NCT) measuring intraocular pressure

    Time frame: 3 months after surgery

  3. Cup/ Disk ( C/ D)

    determine the cup to disc ratio by ophthalmoscope

    Time frame: 3 months after surgery

07

Study locations

1 of 1 sites recruiting
  • Zhognshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) needed to be keep security.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05251792
Responsible party
Sponsor
First posted
Feb 23, 2022
Start date
Nov 11, 2021
Primary completion
Mar 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Feb 13, 2023

Study contacts

Zhihong Huang, M.D
Contact
575772588@qq.com
+8602066615461 ext. 02066615461
Chengguo Zuo, M.D,Ph.D
Contact
chengguozuo@163.com
+8602066615461 ext. 02066615461
Chengguo Zuo
study director · Zhognshan Ophthalmic Center, Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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