Clinical trial NCT05251792: Macular Pigment Optical Density in Primary Angle-closure Disease
Official title: Study on the Relationship Between Macular Pigment Optical Density and Primary Angle-closure Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Glaucoma, Angle-Closure
Macular Pigment Optical Density
Keywords: Glaucoma, Angle-Closure
PACD-Primary Angle Closure Disease
Macular Pigment Optical Density
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients \>=40 years old PACD

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

Eligibility criteria: 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

Primary outcomes:
measure: Macular Pigment Optical Density（MPOD）Measurement
timeFrame: 3 months after surgery
measure: Retinal nerve fiber layer thickness
timeFrame: 3 months after surgery
measure: Ganglion cell complex (GCC)thickness
timeFrame: 3 months after surgery
measure: Mean central retina thickness
timeFrame: 3 months after surgery
measure: Mean outer retinal thickness
timeFrame: 3 months after surgery
measure: Visual Field Test
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Visual acuity
timeFrame: 3 months after surgery
measure: Intraocular pressure
timeFrame: 3 months after surgery
measure: Cup/ Disk ( C/ D）
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhognshan Ophthalmic Center, Sun Yat-sen University
name: Chengguo Zuo
role: STUDY_DIRECTOR
References: