Glaucoma HFA / OCT Specificity Study

Carl Zeiss Meditec

Status: Unknown

Conditions: Glaucoma

Treatments: Device: OCT scanning and HFA perimetry

Study type: Observational

Funder types: Industry

Identifiers

NCT02708082

COMBO-2015-1

Details and patient eligibility

About

Study consists of five visits over a one to three month time period.

Full description

Each visit consists of optical coherence tomography (OCT) scanning (4 scans ) and two HFA (Humphrey Field Analyzer) visual fields of the study eye only.

Enrollment: 90 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult males or females 40 to 80 years old
• Able and willing to attend the required study visits
• Able and willing to provide consent and follow study instructions in English
• A diagnosis by the Principal Investigator or co-investigator of glaucoma, pre-perimetric glaucoma or glaucoma suspect
• Subjects must have experience in threshold automated perimetry, having performed a previous SITA (Swedish Interactive Thresholding Algorithm) threshold test within one year of enrolling to the study
• Ability to fixate that allows obtaining acceptable visual fields and OCT scans in the study eye

Exclusion criteria

• • Best-corrected visual acuity less than 20/40 (study eye only) on a Snellen chart or on a Snellen equivalent acuity chart

  • Spherical refraction outside -12.00 to +5.00 diopters (D) or cylinder correction outside 3.00 D (study eye only)
  • Amblyopia (either eye)
  • Narrow irido-corneal angles or a diagnosis of narrow angle glaucoma
  • Previous or current eye disease in the study eye, serious eye trauma or intraocular surgery (except cataracts with lens implants), or the presence of ocular findings that could affect the visual field, other than glaucoma
  • Cataract surgery in the study eye within six (6) months of first visit
  • Dx of any optic neuropathy other than glaucoma
  • Vitreoretinal traction or epiretinal membrane in the study eye
  • Diagnosis or history of any systemic disease / condition / treatment which is likely to affect the visual field outcome in the Study Eye other than glaucoma
  • History of diabetes, leukemia, AIDS, uncontrolled systemic high blood pressure, dementia or multiple sclerosis
  • Any disease that is likely to progress within the 3 month time period that might have visual field implications
  • A life threatening or debilitating disease
  • Participation in any study involving a non-FDA approved investigational drug (IND) within the past month, or ongoing participation in a study with a non-FDA approved or cleared investigational device (IDE)
  • Concomitant use of hydrochloroquine and/or chloroquine

Trial design

90 participants in 1 patient group

Glaucoma

Description:

Early, moderate or advanced glaucoma, glaucoma suspects or pre-perimetric glaucoma will perform OCT scanning and HFA perimetry

Treatment:

Device: OCT scanning and HFA perimetry