NCT05449041

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

June 29, 2022

Last Update Submit

May 21, 2024

Conditions

Glaucoma EyeCataract

Keywords

Bulbicam

Outcome Measures

Primary Outcomes (42)

  • GAT

    Measurement of eye-pressure in mmHg

    0 hour

  • GAT

    Measurement of eye-pressure in mmHg

    1 hour

  • GAT

    Measurement of eye-pressure in mmHg

    24 hours

  • GAT

    Measurement of eye-pressure in mmHg

    25 hours

  • GAT

    Measurement of eye-pressure in mmHg

    36 hours

  • GAT

    Measurement of eye-pressure in mmHg

    37 hours

  • Visual Field

    Saccadic Reaction Time in ms

    0 hour

  • Visual Field

    Saccadic Reaction Time in ms

    1 hour

  • Visual Field

    Saccadic Reaction Time in ms

    24 hours

  • Visual Field

    Saccadic Reaction Time in ms

    25 hours

  • Visual Field

    Saccadic Reaction Time in ms

    36 hours

  • Visual Field

    Saccadic Reaction Time in ms

    37 hours

  • Ptosis

    MDR in mm

    0 hour

  • Ptosis

    MDR in mm

    1 hour

  • Ptosis

    MDR in mm

    24 hours

  • Ptosis

    MDR in mm

    25 hours

  • Ptosis

    MDR in mm

    36 hours

  • Ptosis

    MDR in mm

    37 hours

  • Dynamic Acuity

    Vision acuity in LogMar

    0 hour

  • Dynamic Acuity

    Vision acuity in LogMar

    1 hour

  • Dynamic Acuity

    Vision acuity in LogMar

    24 hours

  • Dynamic Acuity

    Vision acuity in LogMar

    25 hours

  • Dynamic Acuity

    Vision acuity in LogMar

    36 hours

  • Dynamic Acuity

    Vision acuity in LogMar

    37 hours

  • Dynamic Contrast

    Contrast sensitivity in LogCon

    0 hour

  • Dynamic Contrast

    Contrast sensitivity in LogCon

    1 hour

  • Dynamic Contrast

    Contrast sensitivity in LogCon

    24 hours

  • Dynamic Contrast

    Contrast sensitivity in LogCon

    25 hours

  • Dynamic Contrast

    Contrast sensitivity in LogCon

    36 hours

  • Dynamic Contrast

    Contrast sensitivity in LogCon

    37 hours

  • Dark Adaptation

    Fixed contrast; variable frequency in Hz

    0 hour

  • Dark Adaptation

    Fixed contrast; variable frequency in Hz

    1 hour

  • Dark Adaptation

    Fixed contrast; variable frequency in Hz

    24 hours

  • Dark Adaptation

    Fixed contrast; variable frequency in Hz

    25 hours

  • Dark Adaptation

    Fixed contrast; variable frequency in Hz

    36 hours

  • Dark Adaptation

    Fixed contrast; variable frequency in Hz

    37 hours

  • Pupil

    Diameter (mm)

    0 hour

  • Pupil

    Diameter (mm)

    1 hour

  • Pupil

    Diameter (mm)

    24 hours

  • Pupil

    Diameter (mm)

    25 hours

  • Pupil

    Diameter (mm)

    36 hours

  • Pupil

    Diameter (mm)

    37 hours

Study Arms (4)

Glaucoma patients

Patients diagnosed with Glaucoma of both gender; passed the age of 18 years; without any other eye disease; suffering from other know serious disease but have a health situation in accordance with expectations related to the age.

Device: Bulbicam

Glaucoma controlls

Gender- and age-matched controls to the Glaucoma patients, passed the age of 18 years without any eye diseases; not suffering from other know serious disease and have a health situation in accordance with expectations related to the age.

Device: Bulbicam

Cateract patients

Patients diagnosed with Cataract of both gender; passed the age of 18 years; without any other eye disease; suffering from other know serious disease but have a health situation in accordance with expectations related to the age.

Device: Bulbicam

Cataract controlls

Gender- and age-matched controls to the Cataract patients, passed the age of 18 years without any eye diseases; not suffering from other know serious disease and have a health situation in accordance with expectations related to the age.

Device: Bulbicam

Interventions

BulbicamDEVICE

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

Also known as: Standard eye examination devices
Cataract controllsCateract patientsGlaucoma controllsGlaucoma patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study consists of the following three study populations: 1) Patients suffering from GLA of both genders above 18 years of age with different disease degree; 2) Patients suffering from CAT of both genders above 18 years of age with different disease degree; 3) Gender- and age-matched HC without any eye diseases.

You may qualify if:

  • Patients diagnosed with either Glaucoma or Cataract of both gender
  • Passed the age of 18 years
  • Without any other eye disease

You may not qualify if:

  • Other visual disturbances and blindness
  • Posterior Chamber Intraocular Lens (PCIOL)
  • Physical or psychiatric disease, which may disturb the measuring procedure
  • Patients who are not able to perform eye movements, so no full paresis of any ocular muscles
  • Patients whose visual acuity is less than 0.1 in any eye, as these will not be able to focus on the test stimuli.
  • Patients whose visible part of the eye is abnormal, such as subconjunctival hemorrhages or deformed pupils
  • Patients whose pupils are not able to respond normally to dilation or contraction due to damaged nerves, mechanical damage of the pupil etc.
  • With known alcoholic and drug dependency
  • Not able to understand information.
  • Not willing to give written consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meddoc

Skjetten, Akershus, 2013, Norway

Location

Related Publications (1)

  • Sverstad A, Helland-Hansen BA, Kristianslund O, Kolko M, Larsen SE, Petrovski G. Eye-tracking biomarkers for glaucoma based on saccadic reaction time: a controlled clinical study. Front Ophthalmol (Lausanne). 2025 Oct 16;5:1636911. doi: 10.3389/fopht.2025.1636911. eCollection 2025.

    PMID: 41180014DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Goran Petrovski, PhD

    Oslo University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
5 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research director

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 8, 2022

Study Start

January 10, 2023

Primary Completion

April 30, 2023

Study Completion

May 31, 2023

Last Updated

May 22, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)