Comparison of retinal nerve fiber layer defect detection between color, red-free, and High-Dynamic-Range (HDR) disc photography

• Register: TCTR
• Last refreshed on: 1 April 2024
• Main ID: TCTR20161008002
• Date of registration: 08/10/2016
• Prospective Registration: No
• Primary sponsor: Ratchadaphiseksomphot Fund
• Public title: Comparison of retinal nerve fiber layer defect detection between color, red-free, and High-Dynamic-Range (HDR) disc photography
• Scientific title: Comparison of retinal nerve fiber layer defect detection between color, red-free, and High-Dynamic-Range (HDR) disc photography
• Date of first enrolment: 30/09/2016
• Target sample size: 36
• Recruitment status: Recruiting
• URL: https://www.thaiclinicaltrials.org/show/TCTR20161008002
• Study type: Observational
• Study design: N/A
• Phase: N/A

Countries of recruitment

Thailand

Contacts

• Name: Ubonwan Rasaruck
• Affiliation: Department of Opthalmology, Chulalongkorn University

• Name: Ubonwan Rasaruck
• Affiliation: Department of Opthalmology, Chulalongkorn University

Key inclusion & exclusion criteria

Inclusion criteria: Glaucoma group
1. Age > 40 years
2. Diagnosis by glaucoma specialist
3. At least 2/3 of the following
3.1 Vertical cup to disc ratio greater than 97.5th percentile of normal population
3.2 RNFLD in C-DP or OCT
3.3 Visual field defect in SAP correlated to C-DP or OCT

Glaucoma + media opacity group
1. Age > 40 years
2. Diagnosis by glaucoma specialist
3. At least 2/3 of the following
3.1 Vertical cup to disc ratio greater than 97.5th percentile of normal population
3.2 RNFLD in C-DP or OCT
3.3 Visual field defect in SAP correlated to C-DP or OCT
4.Lens opacity according to LOCS III criteria : at least 1/3 of
4.1 lens opacity 2.0 for nuclear (NO) cataract
4.2 lens opacity 4.0 for cortical cataract (C)
4.3 any posterior subcapsular opacity (P)
5. Image quality (compare with standard disc photo) : at least 1/3 of
5.1 Poor overall image clarity
5.2 Poor defined blood vessel edges
5.3 Poor quality of RNFL

Control group
1. Age > 40 years
2. Vertical cup to disc ratio less than 97.5th percentile of normal population
3. No pathological change in RNFL by C-DP, OCT and SAP

Control + media opacity group
1. Age > 40 years
2. Vertical cup to disc ratio less than 97.5th percentile of normal population
3. No pathological change in RNFL by C-DP, OCT and SAP
4.Lens opacity according to LOCS III criteria : at least 1/3 of
4.1 lens opacity 2.0 for nuclear (NO) cataract
4.2 lens opacity 4.0 for cortical cataract (C)
4.3 any posterior subcapsular opacity (P)
5. Image quality (compare with standard disc photo) : at least 1/3 of
5.1 Poor overall image clarity
5.2 Poor defined blood vessel edges
5.3 Poor quality of RNFL
Exclusion criteria: 1. Retinal or neurological eye disease
2. Intraocular trauma
3. Uncooperative patient
4. Contraindicate for pupil dilatation
5. Poor quality OCT
6. Unreliable VF perimetry
7. Spherical refractive error more than five diopters

Age minimum: 41 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Glaucoma
High-Dynamic-Range (HDR)
retinal nerve fiber layer defect detection
general ophthalmologists
glaucoma

High-Dynamic-Range (HDR)
retinal nerve fiber layer defect detection
general ophthalmologists
glaucoma

Intervention(s)

Glaucoma group,Glaucoma + media opacity group,Control group,Control + media opacity group

Disc photo from glaucoma patients,Disc photo from glaucoma with lens opacity patients,Disc photo from normal volunteers,Disc photo from normal volunteers with lens opacity patients

Diagnostic,Diagnostic,Diagnostic,Diagnostic

Primary Outcome(s)

Capability of retinal nerve fiber layer defect detection between color, red-free, and HDR disc photo Cross-sectional sensitivity, specificity, PPV, NPV, Mean difference ± SD of sensitivity and specificity

Secondary Outcome(s)

Capability of RNFLD detection in images with media opacities between 3 methods Cross-sectional sensitivity, specificity, PPV, NPV, Mean difference ± SD of sensitivity and specificity

Secondary ID(s)

RA59/094

Source(s) of Monetary Support

Ratchadaphiseksomphot Fund

Secondary Sponsor(s)

Ratchadaphiseksomphot Fund

Results

• Date Completed: 31/01/2017