Eye DiseasesNCT05876689
Swept Source OCT Imaging With the DREAM VG-OCT
An observational study of Eye Diseases and Myopia, run by Robert T. Chang, MD at 1 site in United States.
Trial summary
The Intalight Dream OCT is the first combo anterior plus posterior device to perform both OCT and OCT-A at depth of 16mm. This is especially useful in patient who are very nearsighted as it allows us to image all in one frame. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Diseases, Myopia, Glaucoma
- What is being tested?
- DREAM OCT
- Type of treatment
- Medical device
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2023to 1 Oct 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The investigators will be imaging 100 eyes (50 patients unless there are monocular patients) from all genders and ethnic backgrounds who are moderate-high myopes with or without the diagnosis of glaucoma.
Who may be able to join
- Age greater than or equal to 18
- Myopes with a current or previously documented spherical equivalent refraction < -4D
- At least half of the subjects should have had at least one Cirrus OCT RNFL and macula performed as well as a Humphrey visual field performed in those with OCT abnormalities
Who cannot join
- Unable to comply with study imaging
- unclear ocular media
- Participant has, in the opinion of the investigator, any physical or mental condition that would affect the participation in the study or may interfere with the study procedures, evaluations and outcome assessments.
Trial locations and contacts
1 site in 1 country.
About this study
The Intalight Dream OCT is the first combo anterior plus posterior device to perform both OCT and OCT-A at depth of 16mm. This is especially useful in patient who are very nearsighted as it allows us to image all in one frame. The intention of this study is to see how the images differ on the same patients when compared to the Cirrus OCT and to test for the repeatability of the images on a single day.
- Conditions
- Eye Diseases, Myopia, Glaucoma
- Being tested
- DREAM OCT
- Medical subject headings
- Eye Diseases, Myopia, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DREAM OCTDevice
Swept Source OCT (similar to Zeiss Plex Elite)
| Study group | Role | What they receive |
|---|---|---|
| DREAM OCT | All 50 patients will have both eyes (if able) imaged, 3 times, on the same day during their clinic visit. Receives: Device: DREAM OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing difference in intraocular structures
Assessing the performance of the DREAM VG OCT scan patterns in high myopes including glaucomatous eyes to see if there are differences in the lamina cribrosa structure when compared to patients previous Cirrus OCTs.
Measured: Baseline
Assessing difference in intraocular vascular structures
Assessing differences in vascular density in areas with presumed myopic-related field defects vs. low tension glaucoma perimetric disease
Measured: Baseline
Secondary outcomes (1)
Assessing repeatability of scans
Analyze the repeatability of quantitative RNFL and GCC parameters.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start9 Oct 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert T. Chang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert T. Chang, MD, Stanford University
- Investigators
- Robert Chang, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876689
- Sponsor's protocol ID
- 70411
- Status last verified
- Nov 2024
- First submitted
- 17 May 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swept Source OCT Imaging With the DREAM VG-OCT
- ClinicalTrials.gov ID
- NCT05876689
- Acronym / sponsor ID
- 70411
- Conditions
- Eye Diseases, Myopia, Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Robert T. Chang, MDUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 25 May 2023 (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 Intalight Dream OCT is the first combo anterior plus posterior device to perform both OCT and OCT-A at depth of 16mm. This is especially useful in patient who are very nearsighted as it allows us to image all in one frame. The intention of this study is to see how the images differ on the same patients when compared to the Cirrus OCT and to test for the repeatability of the images on a single day.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DREAM OCT | – | Device: DREAM OCTAll 50 patients will have both eyes (if able) imaged, 3 times, on the same day during their clinic visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The investigators will be imaging 100 eyes (50 patients unless there are monocular patients) from all genders and ethnic backgrounds who are moderate-high myopes with or without the diagnosis of glaucoma.
Key inclusion criteria (3 listed)
- Age greater than or equal to 18
- Myopes with a current or previously documented spherical equivalent refraction < -4D
- At least half of the subjects should have had at least one Cirrus OCT RNFL and macula performed as well as a Humphrey visual field performed in those with OCT abnormalities
Key exclusion criteria (3 listed)
- Unable to comply with study imaging
- unclear ocular media
- Participant has, in the opinion of the investigator, any physical or mental condition that would affect the participation in the study or may interfere with the study procedures, evaluations and outcome assessments.
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 |
|---|---|---|
| DREAM OCTSwept Source OCT (similar to Zeiss Plex Elite) | Device | DREAM OCT |
Primary outcome
Assessing difference in intraocular structures
Time frame: Baseline
Assessing the performance of the DREAM VG OCT scan patterns in high myopes including glaucomatous eyes to see if there are differences in the lamina cribrosa structure when compared to patients previous Cirrus OCTs.
Assessing difference in intraocular vascular structures
Time frame: Baseline
Assessing differences in vascular density in areas with presumed myopic-related field defects vs. low tension glaucoma perimetric disease
1 secondary outcome
Assessing repeatability of scans
Time frame: Baseline
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 25 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Robert Chang, MD principal investigator
Stanford University
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 Eye Diseases and Myopia, run by Robert T. Chang, MD at 1 site in United States.
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 3 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 25 Nov 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 United States. 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?
Assessing difference in intraocular structures (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2024.