Elasticum, Incomplete PseudoxanthomaNCT06050629
The Characteristics of Backscattering With Depth in the Progression of Keratoconus
An observational study of Elasticum, Incomplete Pseudoxanthoma, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
To investigate the variation in backscattering with depth between forme fruste keratoconus (FFKC), keratoconus, and normal eyes; to determine the backscattering changes in the characteristics of keratoconus progression; and to explore the diagnostic value of backscattering in FFKC. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Elasticum, Incomplete Pseudoxanthoma
- How many people
- 223 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Dec 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study was performed on patients with keratoconus and healthy participants admitted to Tianjin Eye Hospital from January 2020 to December 2022.
Who may be able to join
- BCVA <20/20 and a history of myopia or astigmatism;
- presence of any of the following positive signs on slit lamp examination: corneal stromal thinning, cone-shaped anterior protrusions, Fleischer's ring, Vogt's striae, epithelial or subepithelial scarring;
- abnormal corneal topography (maximum keratometry (K) value of >47.2 diopters (D), bow-tie pattern with skewed radial axes, or inferior-superior asymmetry(3-mm I-S keratometric difference >1.4 D).
Who cannot join
- 1. Patients with severe corneal scarring that affected light scattering and density maps showing "black holes" 2.Participatients with other corneal diseases 3. Eyes that have undergone surgery or trauma 4. Eyes with corneal dystrophy
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Characteristics of Backscattering With Depth in the Progression of Keratoconus and Its Role in Forme Fruste Keratoconus Detection
To investigate the variation in backscattering with depth between forme fruste keratoconus (FFKC), keratoconus, and normal eyes; to determine the backscattering changes in the characteristics of keratoconus progression; and to explore the diagnostic value of backscattering in FFKC.
Read the detailed description
To investigate the variation in backscattering with depth between forme fruste keratoconus (FFKC), keratoconus, and normal eyes; to determine the backscattering changes in the characteristics of keratoconus progression; and to explore the diagnostic value of backscattering in FFKC. A Scheimpflug corneal tomography image and caliper tool were used to obtain backscatter at every 2% depth at the thinnest point of the cornea, with the measured values expressed in grayscale units (GSU).
- Conditions
- Elasticum, Incomplete Pseudoxanthoma
- Medical subject headings
- Pseudoxanthoma Elasticum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| forme fruste keratoconus | 1) no other eye abnormalities except myopia and astigmatism; 2) transparent cornea; 3) no positive signs of keratoconus on slit lamp examination or morphology examination (excluding the appearance of keratoconus as described above, and simultaneously satisfying A0B0C0D0, Index of Surface variance (ISV) < 30, and Keratoconus Index (KI) < 1.07); and 4) Belin/Ambrósio enhanced ectasia total derivation value(BAD-D)≤1.6 | |
| Clinical keratoconus | 46.5 D ≤ Mean K <52 D; 55≤ ISV<200; and 1.10 ≤ KI <1.50 | |
| severe keratoconus | Mean K ≥ 52D; ISV≥ 200; and KI≥ 1.50 | |
| normal eye | one eye of healthy participants before refractive surgery were randomly selected. Comprehensive ophthalmic examinations were performed before surgery, which confirmed that the cornea was clear and normal in shape. For this group, there was no family history of keratoconus, no other diseases except ametropia, and no corneal dilatation one year after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
backscattering
Standard measurements were performed using a Pentacam (Pentacam HR; Oculus, Wetzlar, Germany);The average brightness of a predetermined area of the cornea was calculated, shown as densitometry, and recorded in GSU ranging from 0 to 100 (0, cornea is transparent without opacity; 100, cornea is completely opaque).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Jan 2020
- Primary completion1 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elasticum, Incomplete PseudoxanthomaStudies 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
- Retrospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050629
- Sponsor's protocol ID
- KY-2023020
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics of Backscattering With Depth in the Progression of Keratoconus and Its Role in Forme Fruste Keratoconus Detection
- ClinicalTrials.gov ID
- NCT06050629
- Acronym / sponsor ID
- KY-2023020
- Conditions
- Elasticum, Incomplete Pseudoxanthoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 22 Sep 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.
To investigate the variation in backscattering with depth between forme fruste keratoconus (FFKC), keratoconus, and normal eyes; to determine the backscattering changes in the characteristics of keratoconus progression; and to explore the diagnostic value of backscattering in FFKC.
Detailed description
To investigate the variation in backscattering with depth between forme fruste keratoconus (FFKC), keratoconus, and normal eyes; to determine the backscattering changes in the characteristics of keratoconus progression; and to explore the diagnostic value of backscattering in FFKC. A Scheimpflug corneal tomography image and caliper tool were used to obtain backscatter at every 2% depth at the thinnest point of the cornea, with the measured values expressed in grayscale units (GSU).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| forme fruste keratoconus | – | –1) no other eye abnormalities except myopia and astigmatism; 2) transparent cornea; 3) no positive signs of keratoconus on slit lamp examination or morphology examination (excluding the appearance of keratoconus as described above, and simultaneously satisfying A0B0C0D0, Index of Surface variance (ISV) < 30, and Keratoconus Index (KI) < 1.07); and 4) Belin/Ambrósio enhanced ectasia total derivation value(BAD-D)≤1.6 |
| Clinical keratoconus | – | –46.5 D ≤ Mean K <52 D; 55≤ ISV<200; and 1.10 ≤ KI <1.50 |
| severe keratoconus | – | –Mean K ≥ 52D; ISV≥ 200; and KI≥ 1.50 |
| normal eye | – | –one eye of healthy participants before refractive surgery were randomly selected. Comprehensive ophthalmic examinations were performed before surgery, which confirmed that the cornea was clear and normal in shape. For this group, there was no family history of keratoconus, no other diseases except ametropia, and no corneal dilatation one year after surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study was performed on patients with keratoconus and healthy participants admitted to Tianjin Eye Hospital from January 2020 to December 2022.
Key inclusion criteria (3 listed)
- BCVA <20/20 and a history of myopia or astigmatism;
- presence of any of the following positive signs on slit lamp examination: corneal stromal thinning, cone-shaped anterior protrusions, Fleischer's ring, Vogt's striae, epithelial or subepithelial scarring;
- abnormal corneal topography (maximum keratometry (K) value of >47.2 diopters (D), bow-tie pattern with skewed radial axes, or inferior-superior asymmetry(3-mm I-S keratometric difference >1.4 D).
Key exclusion criteria (2 listed)
- 1. Patients with severe corneal scarring that affected light scattering and density maps showing "black holes" 2.Participatients with other corneal diseases 3. Eyes that have undergone surgery or trauma 4. Eyes with corneal dystrophy
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
backscattering
Time frame: through study completion, an average of 1 year
Standard measurements were performed using a Pentacam (Pentacam HR; Oculus, Wetzlar, Germany);The average brightness of a predetermined area of the cornea was calculated, shown as densitometry, and recorded in GSU ranging from 0 to 100 (0, cornea is transparent without opacity; 100, cornea is completely opaque).
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 Sep 2023.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Elasticum, Incomplete Pseudoxanthoma, run by Tianjin Eye Hospital at 1 site in China.
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 2 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 Sep 2023. 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 China. 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?
backscattering (time frame: through study completion, an average of 1 year). 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 22 Sep 2023.