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Macular Pigment Optical Density in Primary Angle-closure Disease

Recruiting
Conditions
Glaucoma
Glaucoma, Angle-Closure
Macular Pigment Optical Density
Interventions
Other: Ocular examination
Registration Number
NCT05251792
Lead Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
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

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

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
60
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Primary Angle Clousure Diseases EyesOcular 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 EyesOcular examinationHealthy population matched by sex and age.
Primary Outcome Measures
NameTimeMethod
Macular Pigment Optical Density(MPOD)Measurement3 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 thickness3 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.

Visual Field Test3 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

Mean central retina thickness3 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 thickness3 months after surgery

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

Ganglion cell complex (GCC)thickness3 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.

Secondary Outcome Measures
NameTimeMethod
Visual acuity3 months after surgery

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

Intraocular pressure3 months after surgery

Using non-contact tonometer (NCT) measuring intraocular pressure

Cup/ Disk ( C/ D)3 months after surgery

determine the cup to disc ratio by ophthalmoscope

Trial Locations

Locations (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

🇨🇳

Guangzhou, Guangdong, China

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