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Bulbicam Validation on Glaucoma- and Cataract Patients

NCT05449041 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2024-05-22

No results posted yet for this study

Summary

The aim is to investigate repeatability and stability of the six OTH-related Bulbicam tests in patients suffering from Glaucoma (GLA), b) Cataract (CAT) and matched healthy controls (HC).

The study population consists of the three subpopulations: 1) Patients suffering from GLA; 2) Patients suffering from CAT and 3) Gender- and age-matched HC without any eye diseases.

Bulbicam will be used in the study including six tests and the standard method will be used initially for measurements of "Visual Field" and "Pupil"

The study will be performed as a controlled, open, and non-randomized, stratified observational single center study. The stratification factors will be pathology and the degree of disease. Within each of the four strata, healthy matched controls related to gender and age (1:1) will be included.

The main variables will be the variables recorded at the six Bulbicam and the supporting variables will be recorded by the Standard (ST) investigation. The central variables related to Glaucoma will be the GAT and iCare pressure, "Seen /unseen "," Time until the given point is recorded as seen", "the light in decibel when the point is seen", X- and Y-coordinates and "Pupil diameter in mm".

The central variables related to cataract will be "Pupil diameter", "OCT RNFL ", "Seen /unseen "," Time until the given point is recorded as seen", "the light in decibel when the point is seen" and the X- and Y-coordinates.

Participants, who fulfil the inclusion criteria; do not meet any of the exclusion criteria and willing to give informed consent to participate will receive an appointment for starting the study. The Bulbicam examination will be performed twice a day with a rest period of one hour between each registration. This procedure will be repeated the following two days. All demographic data, social factors and history of disease will be recorded at screening.

Sixteen GLA-patients and 16 CAT-patients equally divided into two substrata will be recruited from the two participating hospitals. For each included patient, one gender- and age-matched HC will be recruited. In total 16 GLA-patients with 16 HC and 16 CAT-patients with 16 HC will be included in the study.

Conditions

  • Glaucoma Eye
  • Cataract

Interventions

DEVICE

Bulbicam

Measurement of eye pressure; Accuracy diagram; Contrast chart; Visual field, Pupil size

Sponsors & Collaborators

  • Meddoc

    lead OTHER

Principal Investigators

  • Goran Petrovski, PhD · Oslo University Hospital

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2023-04-30
Completion
2023-05-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05449041 on ClinicalTrials.gov