Glaucoma EyeNCT05449041
Bulbicam Validation on Glaucoma- and Cataract Patients
An observational study of Glaucoma Eye and Cataract, run by Meddoc at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma Eye, Cataract
- What is being tested?
- Bulbicam
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 1 siteNorway
- Study dates
- 10 Jan 2023to 31 May 2023
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with either Glaucoma or Cataract of both gender
- Passed the age of 18 years
- Without any other eye disease
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Bulbicam for Use on Patient Suffering From Glaucoma (GLA) and Cataract (CAT)
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.
Read more
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.
Read the detailed description
Aim
- To investigate repeatability and stability of the six OTH-related Bulbicam tests in patients suffering from a) Glaucoma (GLA), b) Cataract (CAT) and matched healthy controls (HC).
- To compare Bulbicam and the standard method on measurements of Visual field and Pupil
- To contribute to establishment of normal range for GLA and CAT patients with different degrees in the disease development related to the Bulbicam tests.
- To contribute to establishment of normal range for a normal population without eye-disease related to the Bulbicam tests. Study population 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.
Trial equipment: Bulbicam will be used in the study and the following six tests will be performed at each investigation: "Visual Field", "Ptosis", Dynamic Acuity", "Dynamic Contrast ", "Dark Adaption" and "Pupil". The standard method will be used initially for measurements of "Visual Field" and "Pupil"
Design:
The study will be performed as a controlled, open, and non-randomized, stratified observational single center study. The stratification factors will be pathology (GLA\&CAT) 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 degree of GLA is defined as follows:
- Mild glaucoma
- Moderate glaucoma
- Severe glaucoma
The degree of CAT is defined as follows:
- Cataract Nuclear Sclerosis - Grade 1
- Cataract Nuclear Sclerosis - Grade 2
Higher grade cataracts are difficult to have occurred in Norway and thus excluded from this study.
For each included patient, a gender- and age-matched HV will be included. All included participants will perform Bulbicam eye-investigation twice at three flowing days with a rest period of at least one hour. Each investigation includes same six Bulbicam tests. The Standard method will only be performed once as the first investigation at day 1 for measurements of "Visual Field" and "Pupil".
Main variables will be the variables recorded at the six Bulbicam tests. Supporting Variables will be recorded by the Standard (ST) investigation for Glaucoma and Cataract.
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.
Study procedure:
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. Additionally, the quality of life (QoL) questionnaires EQ-5D-5L developed by EuroQol will be recorded initially as individual baseline values. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for measuring and classifying the tolerability and toxicity at the end of each day of investigation.
Sample size:
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. All together the study will include 64 participants.
- Conditions
- Glaucoma Eye, Cataract
- Being tested
- Bulbicam
- Keywords
- Bulbicam
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BulbicamDevice
Also called Standard eye examination devices
Measurement of eye pressure; Accuracy diagram; Contrast chart; Visual field, Pupil size
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Bulbicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAT
Measurement of eye-pressure in mmHg
Measured: 0 hour
GAT
Measurement of eye-pressure in mmHg
Measured: 1 hour
GAT
Measurement of eye-pressure in mmHg
Measured: 24 hours
GAT
Measurement of eye-pressure in mmHg
Measured: 25 hours
GAT
Measurement of eye-pressure in mmHg
Measured: 36 hours
GAT
Measurement of eye-pressure in mmHg
Measured: 37 hours
Visual Field
Saccadic Reaction Time in ms
Measured: 0 hour
Visual Field
Saccadic Reaction Time in ms
Measured: 1 hour
Visual Field
Saccadic Reaction Time in ms
Measured: 24 hours
Visual Field
Saccadic Reaction Time in ms
Measured: 25 hours
Visual Field
Saccadic Reaction Time in ms
Measured: 36 hours
Visual Field
Saccadic Reaction Time in ms
Measured: 37 hours
Ptosis
MDR in mm
Measured: 0 hour
Ptosis
MDR in mm
Measured: 1 hour
Ptosis
MDR in mm
Measured: 24 hours
Ptosis
MDR in mm
Measured: 25 hours
Ptosis
MDR in mm
Measured: 36 hours
Ptosis
MDR in mm
Measured: 37 hours
Dynamic Acuity
Vision acuity in LogMar
Measured: 0 hour
Dynamic Acuity
Vision acuity in LogMar
Measured: 1 hour
Dynamic Acuity
Vision acuity in LogMar
Measured: 24 hours
Dynamic Acuity
Vision acuity in LogMar
Measured: 25 hours
Dynamic Acuity
Vision acuity in LogMar
Measured: 36 hours
Dynamic Acuity
Vision acuity in LogMar
Measured: 37 hours
Dynamic Contrast
Contrast sensitivity in LogCon
Measured: 0 hour
Dynamic Contrast
Contrast sensitivity in LogCon
Measured: 1 hour
Dynamic Contrast
Contrast sensitivity in LogCon
Measured: 24 hours
Dynamic Contrast
Contrast sensitivity in LogCon
Measured: 25 hours
Dynamic Contrast
Contrast sensitivity in LogCon
Measured: 36 hours
Dynamic Contrast
Contrast sensitivity in LogCon
Measured: 37 hours
Dark Adaptation
Fixed contrast; variable frequency in Hz
Measured: 0 hour
Dark Adaptation
Fixed contrast; variable frequency in Hz
Measured: 1 hour
Dark Adaptation
Fixed contrast; variable frequency in Hz
Measured: 24 hours
Dark Adaptation
Fixed contrast; variable frequency in Hz
Measured: 25 hours
Dark Adaptation
Fixed contrast; variable frequency in Hz
Measured: 36 hours
Dark Adaptation
Fixed contrast; variable frequency in Hz
Measured: 37 hours
Pupil
Diameter (mm)
Measured: 0 hour
Pupil
Diameter (mm)
Measured: 1 hour
Pupil
Diameter (mm)
Measured: 24 hours
Pupil
Diameter (mm)
Measured: 25 hours
Pupil
Diameter (mm)
Measured: 36 hours
Pupil
Diameter (mm)
Measured: 37 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start10 Jan 2023
- Primary completion30 Apr 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Meddoc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Stig Larsen, Meddoc
- Investigators
- Goran Petrovski, PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449041
- Sponsor's protocol ID
- V2_OTH/GLA;CAT-I/2022
- Status last verified
- May 2024
- First submitted
- 29 Jun 2022
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41180014
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Bulbicam for Use on Patient Suffering From Glaucoma (GLA) and Cataract (CAT)
- ClinicalTrials.gov ID
- NCT05449041
- Acronym / sponsor ID
- V2_OTH/GLA;CAT-I/2022
- Conditions
- Glaucoma Eye, Cataract
- Keywords
- Bulbicam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- MeddocUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim
- To investigate repeatability and stability of the six OTH-related Bulbicam tests in patients suffering from a) Glaucoma (GLA), b) Cataract (CAT) and matched healthy controls (HC).
- To compare Bulbicam and the standard method on measurements of Visual field and Pupil
- To contribute to establishment of normal range for GLA and CAT patients with different degrees in the disease development related to the Bulbicam tests.
- To contribute to establishment of normal range for a normal population without eye-disease related to the Bulbicam tests. Study population 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.
Trial equipment: Bulbicam will be used in the study and the following six tests will be performed at each investigation: "Visual Field", "Ptosis", Dynamic Acuity", "Dynamic Contrast ", "Dark Adaption" and "Pupil". The standard method will be used initially for measurements of "Visual Field" and "Pupil"
Design:
The study will be performed as a controlled, open, and non-randomized, stratified observational single center study. The stratification factors will be pathology (GLA\&CAT) 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 degree of GLA is defined as follows:
- Mild glaucoma
- Moderate glaucoma
- Severe glaucoma
The degree of CAT is defined as follows:
- Cataract Nuclear Sclerosis - Grade 1
- Cataract Nuclear Sclerosis - Grade 2
Higher grade cataracts are difficult to have occurred in Norway and thus excluded from this study.
For each included patient, a gender- and age-matched HV will be included. All included participants will perform Bulbicam eye-investigation twice at three flowing days with a rest period of at least one hour. Each investigation includes same six Bulbicam tests. The Standard method will only be performed once as the first investigation at day 1 for measurements of "Visual Field" and "Pupil".
Main variables will be the variables recorded at the six Bulbicam tests. Supporting Variables will be recorded by the Standard (ST) investigation for Glaucoma and Cataract.
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.
Study procedure:
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. Additionally, the quality of life (QoL) questionnaires EQ-5D-5L developed by EuroQol will be recorded initially as individual baseline values. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for measuring and classifying the tolerability and toxicity at the end of each day of investigation.
Sample size:
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. All together the study will include 64 participants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Glaucoma patients | – | Device: BulbicamPatients 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. |
| Glaucoma controlls | – | Device: BulbicamGender- 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. |
| Cateract patients | – | Device: BulbicamPatients 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. |
| Cataract controlls | – | Device: BulbicamGender- 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients diagnosed with either Glaucoma or Cataract of both gender
- Passed the age of 18 years
- Without any other eye disease
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BulbicamAlso: Standard eye examination devicesMeasurement of eye pressure; Accuracy diagram; Contrast chart; Visual field, Pupil size | Device | Cataract controlls, Cateract patients, Glaucoma controlls, Glaucoma patients |
Primary outcome
GAT
Time frame: 0 hour
Measurement of eye-pressure in mmHg
GAT
Time frame: 1 hour
Measurement of eye-pressure in mmHg
GAT
Time frame: 24 hours
Measurement of eye-pressure in mmHg
GAT
Time frame: 25 hours
Measurement of eye-pressure in mmHg
GAT
Time frame: 36 hours
Measurement of eye-pressure in mmHg
GAT
Time frame: 37 hours
Measurement of eye-pressure in mmHg
Visual Field
Time frame: 0 hour
Saccadic Reaction Time in ms
Visual Field
Time frame: 1 hour
Saccadic Reaction Time in ms
Visual Field
Time frame: 24 hours
Saccadic Reaction Time in ms
Visual Field
Time frame: 25 hours
Saccadic Reaction Time in ms
Visual Field
Time frame: 36 hours
Saccadic Reaction Time in ms
Visual Field
Time frame: 37 hours
Saccadic Reaction Time in ms
Ptosis
Time frame: 0 hour
MDR in mm
Ptosis
Time frame: 1 hour
MDR in mm
Ptosis
Time frame: 24 hours
MDR in mm
Ptosis
Time frame: 25 hours
MDR in mm
Ptosis
Time frame: 36 hours
MDR in mm
Ptosis
Time frame: 37 hours
MDR in mm
Dynamic Acuity
Time frame: 0 hour
Vision acuity in LogMar
Dynamic Acuity
Time frame: 1 hour
Vision acuity in LogMar
Dynamic Acuity
Time frame: 24 hours
Vision acuity in LogMar
Dynamic Acuity
Time frame: 25 hours
Vision acuity in LogMar
Dynamic Acuity
Time frame: 36 hours
Vision acuity in LogMar
Dynamic Acuity
Time frame: 37 hours
Vision acuity in LogMar
Dynamic Contrast
Time frame: 0 hour
Contrast sensitivity in LogCon
Dynamic Contrast
Time frame: 1 hour
Contrast sensitivity in LogCon
Dynamic Contrast
Time frame: 24 hours
Contrast sensitivity in LogCon
Dynamic Contrast
Time frame: 25 hours
Contrast sensitivity in LogCon
Dynamic Contrast
Time frame: 36 hours
Contrast sensitivity in LogCon
Dynamic Contrast
Time frame: 37 hours
Contrast sensitivity in LogCon
Dark Adaptation
Time frame: 0 hour
Fixed contrast; variable frequency in Hz
Dark Adaptation
Time frame: 1 hour
Fixed contrast; variable frequency in Hz
Dark Adaptation
Time frame: 24 hours
Fixed contrast; variable frequency in Hz
Dark Adaptation
Time frame: 25 hours
Fixed contrast; variable frequency in Hz
Dark Adaptation
Time frame: 36 hours
Fixed contrast; variable frequency in Hz
Dark Adaptation
Time frame: 37 hours
Fixed contrast; variable frequency in Hz
Pupil
Time frame: 0 hour
Diameter (mm)
Pupil
Time frame: 1 hour
Diameter (mm)
Pupil
Time frame: 24 hours
Diameter (mm)
Pupil
Time frame: 25 hours
Diameter (mm)
Pupil
Time frame: 36 hours
Diameter (mm)
Pupil
Time frame: 37 hours
Diameter (mm)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Derived from this study: PubMed 41180014Sverstad 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.
- Individual participant dataSharing planned: No
Related trials for Glaucoma Eye
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goran Petrovski, PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma Eye and Cataract, run by Meddoc at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAT (time frame: 0 hour). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05449041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.