Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03080714
Other study ID # Triton AP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 13, 2017
Est. completion date October 30, 2017

Study information

Verified date June 2022
Source Topcon Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To Compare the agreement and precision between the Topcon DRI OCT Triton and the 3D OCT-1 Maestro with RDB.


Description:

The objectives of this study are to compare the agreement and precision between Topcon DRI OCT Triton and 3D OCT-1 Maestro with RDB by measuring the thickness layers.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date October 30, 2017
Est. primary completion date August 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria for Normal Group 1. Subjects 18 years of age or older on the date of informed consent 2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. Subjects presenting at the site with normal eyes bilaterally (cataracts are acceptable) 4. IOP = 21 mmHg bilaterally 5. BCVA 20/40 or better bilaterally Exclusion Criteria for Normal Group 1. Subjects unable to tolerate ophthalmic imaging 2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images 3. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses > 20% or false positives > 33%, or false negatives > 33% 4. Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings: 1. On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; 2. Glaucoma hemi-field test "outside normal limits." 5. Narrow angle 6. History of leukemia, dementia or multiple sclerosis 7. Concomitant use of hydroxychloroquine and chloroquine Inclusion Criteria for Glaucoma Group 1. Subjects 18 years of age or older on the date of informed consent 2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. BCVA 20/40 or better in the study eye 4. Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings: 1. On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; 2. Glaucoma hemi-field test "outside normal limits." 5. Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities: 1. Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; 2. Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or 3. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue Exclusion Criteria for Glaucoma Group 1. Subjects unable to tolerate ophthalmic imaging 2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images 3. HFA visual field (24-2 Sita Standard, white on white) result unreliable, defined as fixation losses > 20% or false positives > 33%, or false negatives > 33% in the study eye 4. Presence of any ocular pathology except glaucoma in the study eye (cataracts are acceptable) 5. History of leukemia, dementia or multiple sclerosis 6. Concomitant use of hydroxychloroquine and chloroquine Inclusion Criteria for Retina Disease Group 1. Subjects 18 years of age or older on the date of informed consent 2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. Subjects presenting at the site with retinal disease 4. IOP = 21 mmHg in the study eye 5. BCVA 20/400 or better in the study eye 6. Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Cystoid Macula Edema, and others Exclusion Criteria for Retinal Disease Group 1. Subjects unable to tolerate ophthalmic imaging 2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images 3. Presence of glaucoma or any ocular pathology other than a Retinal pathology (e.g., cornea pathology) in the study eye (cataracts are acceptable) 4. Narrow angle in the study eye 5. History of leukemia, dementia or multiple sclerosis 6. Concomitant use of hydroxychloroquine and chloroquine

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Topcon DRI OCT Triton (plus)
The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes
3D OCT-1 Maestro
The 3D OCT-1 Maestro is an OCT machine used for diagnostic purposes

Locations

Country Name City State
United States Fischer Laser Eye Center Willmar Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Topcon Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retinal Thickness The thickness of the macula layer 1 Minute
See also
  Status Clinical Trial Phase
Recruiting NCT05414994 - Assessment of the Ocular Microbiome in Health and Disease
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Completed NCT02811692 - Study for Collection of Aflibercept Data in Routine Practice
Recruiting NCT06045299 - Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia Phase 3
Recruiting NCT01521065 - An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Phase 2
Completed NCT04799704 - Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic Patients.
Recruiting NCT05876689 - Swept Source OCT Imaging With the DREAM VG-OCT
Active, not recruiting NCT04123626 - A Study to Evaluate the Safety and Tolerability of QR-1123 in Subjects With Autosomal Dominant Retinitis Pigmentosa Due to the P23H Mutation in the RHO Gene Phase 1/Phase 2
Recruiting NCT04150432 - Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children N/A
Not yet recruiting NCT05550740 - Repeated Low-Level Red-Light Therapy for Shortening Axial Length N/A
Completed NCT02332343 - Sparing of the Fovea in Geographic Atrophy Progression N/A
Completed NCT01727973 - Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy Phase 1/Phase 2
Terminated NCT01225146 - Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2) Phase 1
Completed NCT00333203 - Next Generation Ophthalmic Irrigating Solution Posterior Segment Study Phase 3
Not yet recruiting NCT05565547 - Multimodal Equipment for Teleophthalmology Assessment (META)
Recruiting NCT05158699 - Effectiveness of Periocular Drug Injection in CATaract Surgery Phase 3
Recruiting NCT06451172 - Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis Early Phase 1
Recruiting NCT06112340 - A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) Phase 2/Phase 3
Completed NCT05211089 - Manual Versus Automated Choroidal Thickness Measurements Using Swept-source Anterior Segment OCT
Not yet recruiting NCT06070467 - Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases