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

Not Applicable

Recruiting

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

• Registration Number: TCTR20161008002
• Lead Sponsor: Ratchadaphiseksomphot Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-08
• Study Completion: 2017-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 36

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 RNF

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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