Clinical trial: Clinical Study of the Optic Disc Parameters (NCT02277119)

Eligibility criteria:
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 (eyes without pathology)

          4. lOPs 21mmHg bilaterally

          5. BCVA 20/40 or better (each eye)

          6. Both eyes must be free of eye disease

        Exclusion Criteria for Normal Group

          1. Subjects that have participated in any previous study using 3D OCT-1 Maestro device.

          2. Subjects unable to tolerate ophthalmic imaging

          3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images

          4. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT
             'Outside Normal Limits' and/or PSD < 5%

          5. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on
             manufacturer's recommendation), defined as fixation losses> 33% or false positives >
             25%, or false negatives > 25%

          6. Presence of any ocular pathology except for cataract

          7. Previous ocular surgery or laser treatment, other than uncomplicated refractive
             procedure or cataract surgery, performed within six months prior to study scanning

          8. Narrow angle

          9. History of leukemia, dementia or multiple sclerosis

         10. 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. Subjects presenting at the site with glaucoma

          4. BCVA 20/40 or better in the study eye

          5. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT
             'Outside Normal Limits' and/or PSD < 5% in the study eye

        Exclusion Criteria for Glaucoma Group

          1. Subjects that have participated in any previous study using 3D OCT-1 Maestro device.

          2. Subjects unable to tolerate ophthalmic imaging

          3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images

          4. HFA visual field (24-2 Sita Standard, white on white) result unreliable, defined as
             fixation losses > 33% or false positives > 25%, or false negatives > 25% in the study
             eye

          5. Presence of any ocular pathology except glaucoma in the study eye

          6. Previous ocular surgery or laser treatment, other than uncomplicated refractive
             procedure or cataract surgery, performed within six months prior to study scanning in
             the study eye

          7. History of leukemia, dementia or multiple sclerosis

          8. Concomitant use of hydroxychloroquine and chloroquine

        Inclusion Criteria for Retinal 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. lOP <= 21mmHg 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 Group

          1. Subjects that have participated in any previous study using 3D OCT-1 Maestro device.

          2. Subjects unable to tolerate ophthalmic imaging

          3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images

          4. Presence of glaucoma or any ocular pathology other than a Retinal pathology (e.g.,
             cornea pathology) in the study eye

          5. Previous ocular surgery or laser treatment other than uncomplicated refractive
             procedure or cataract surgery performed within six months prior to study scanning in
             the study eye

          6. Narrow angle in the study eye

          7. History of leukemia, dementia or multiple sclerosis

          8. Concomitant use of hydroxychloroquine and chloroquine
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism.  The patient was born at 38 weeks gestation with no complications.  Vital signs are normal.  Weight and height are at the 50th percentile.  On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination.  Optic nerves are small and gray.  All the hairs including eyebrows and lashes are white.

Patient description (patient's own words): I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray.

Does the patient match the trial criteria? Contradiction