Macular Pigment Optical Density in Primary Angle-closure Disease

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05251792
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 25.6
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Glaucoma, Angle-Closure; Macular Pigment Optical Density	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 Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Study on the Relationship Between Macular Pigment Optical Density and Primary Angle-closure Disease
• Anticipated Study Start Date: Nov 11, 2022
• Anticipated Primary Completion Date: Mar 30, 2024
• Anticipated Study Completion Date: Dec 30, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Macular Pigment Optical Density（MPOD）Measurement [baseline]

   A one-wavelength fundus reflectance method was used for detection of MPOD.

2. Retinal nerve fiber layer thickness [baseline]

   Detection by optical coherence tomography (OCT)

3. Ganglion cell complex (GCC)thickness [baseline]

   The distance from the internal limiting membrane and outer edge of the outer plexiform layer was defined as GCC thickness.

4. Mean central retina thickness [baseline]

   CRT thickness was defined as distance between the internal limiting membrane and the inner edge of the retinal pigment epithelium.

5. Mean defect [baseline]

   Detection by optical coherence tomography (OCT)

6. Visual Field Test [baseline]

   The visual field test using the 30-2 Threshold Test on the Humphrey Visual Field Analyzer

Secondary Outcome Measures

1. Visual acuity [baseline]

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

2. Intraocular pressure [baseline]

   Using non-contact tonometer (NCT) measuring intraocular pressure

3. Ophthalmoscope [baseline]

   Choose specifications for 90D ophthalmoscope

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhongshan Ophthalmic Center, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT05251792
• Other Study ID Numbers: 2020KYPJ82
• First Posted: Feb 23, 2022
• Last Update Posted: Feb 23, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhongshan Ophthalmic Center, Sun Yat-sen University: Glaucoma, Angle-Closure; PACD-Primary Angle Closure Disease; Macular Pigment Optical Density
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Angle-Closure

Study Results

No Results Posted as of Feb 23, 2022