Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT06973694
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2025-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Bulbicam Used on Patient Suffering From Diabetes Without Retinopathy
Sponsor:
Meddoc
Organization:
Study Overview
Official Title:
Validation of Bulbicam Used on Patient Suffering From Diabetes Without Retinopathy
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
\- The study consists of the following two study populations: 1) Patients suffering from diabetes without retinopathy of both genders with various durations of disease 2) Age-matched healthy control (HC) without any eye diseases except for mild catarakt.
Six bulbicam tests together with the standard method will be used in the study.
* The study will be performed as a controlled, open, and non-randomized observational multicenter study. For each included patient and age-matched HC will be included. All included participants will perform Bulbicam eye-investigation six times within 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.
* The main variables will be the variables recorded at the four ACOLAPT- and two Pupil Bulbicam tests.
* 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.
\- Sixteen diabetes-patients with eaual many age-matched HC will be included.
Six bulbicam tests together with the standard method will be used in the study.
* The study will be performed as a controlled, open, and non-randomized observational multicenter study. For each included patient and age-matched HC will be included. All included participants will perform Bulbicam eye-investigation six times within 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.
* The main variables will be the variables recorded at the four ACOLAPT- and two Pupil Bulbicam tests.
* 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.
\- Sixteen diabetes-patients with eaual many age-matched HC will be included.
Detailed Description:
* The study consists of the following two study populations: 1) Patients suffering from diabetes without retinopathy of both genders with various durations of disease 2) Age-matched healthy control (HC) without any eye diseases except for mild catarakt.
* The six bulbicam tests "Visual acuity", "Contrast sensitivity", "Light adaptation latency with fixed frequency and variable contrast", "Light adaptation latency with variable frequency and fixed contrast" and "two pupil tests will be used. The Standard Method will be used initially for measurements of "iCare", "Visual acuity", "Refraction", "Contrast", "OCT" and "Fundus photography".
* The study will be performed as a controlled, open, and non-randomized observational multicenter study. For each included patient and age-matched HC will be included. All included participants will perform Bulbicam eye-investigation six times within 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
* The main variables will be the variables recorded at the four ACOLAPT- and two Pupil Bulbicam tests.
* 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.
* Sixteen diabetes-patients with eaual many age-matched HC will be included.
* The six bulbicam tests "Visual acuity", "Contrast sensitivity", "Light adaptation latency with fixed frequency and variable contrast", "Light adaptation latency with variable frequency and fixed contrast" and "two pupil tests will be used. The Standard Method will be used initially for measurements of "iCare", "Visual acuity", "Refraction", "Contrast", "OCT" and "Fundus photography".
* The study will be performed as a controlled, open, and non-randomized observational multicenter study. For each included patient and age-matched HC will be included. All included participants will perform Bulbicam eye-investigation six times within 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
* The main variables will be the variables recorded at the four ACOLAPT- and two Pupil Bulbicam tests.
* 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.
* Sixteen diabetes-patients with eaual many age-matched HC will be included.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: