Marfan's Syndrome With Ocular ManifestationsNCT04274634
The Oscillation of Crystalline and Intraocular Lenses
An observational study of Marfan's Syndrome With Ocular Manifestations and Pseudoexfoliation Syndrome, run by Anglia Ruskin University at 2 sites in United Kingdom.
Trial summary
The crystalline lens of the human eye helps to sharpen vision. There can be issues with the support/stability of the lens. This could be seen with the naked eye of an external observer or with the use of a slit lamp. Certain eye conditions can predispose to issues with lens stability. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Marfan's Syndrome With Ocular Manifestations, Pseudoexfoliation Syndrome, Cataract
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2020to Mar 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Secondary care, community sample
Who may be able to join
- >18 years old
- Able to read and understand the English language
Who cannot join
- Significant corneal scarring
- Taking medications that cause miosis (pupil constriction)
- Patients with no light perception
- Patients unable to open their eyes e.g. due to significant ptosis
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Vision and Eye Research Institute (VERI)
Cambridge, CB1 2LZ
Megan H Vaughan, 01223695310, megan.vaughan@pgr.anglia.ac.uk
Shahina Pardhan
Southend University Hospital NHS Foundation Trust
Southend-on-Sea, Essex, SS0 0RY
Craig Mackerness, 01702 385089, craig.mackerness@southend.nhs.uk
Aman Chandra, aman.chandra@southend.nhs.uk
About this study
Official title: The Oscillation of Crystalline and Intraocular Lenses: a Feasibility Study of the Lens' Movements in the Eye
The crystalline lens of the human eye helps to sharpen vision. There can be issues with the support/stability of the lens. This could be seen with the naked eye of an external observer or with the use of a slit lamp.
Certain eye conditions can predispose to issues with lens stability. If patients have stability issues with their natural lens- this would be termed as "phakodonesis". However, in patients who have had prior cataract surgery with implantation of an artificial lens (IOL)- this would be termed as "pseudophakodonesis". Eye conditions such as pseudoexfoliation or Marfan-syndrome can lead to unstable lens support- this can be detected if there are advanced stability issues.
Read more
However, small instability in the eye's would not be detected with present descriptive methods. The authors have designed a high-speed camera which is able to detect stability of the lens, especially during eye movements. The high-speed camera can detect variation in the change of light reflex from the lens and calculate the amount of lens instability/oscillation. The results (in normal eyes) of this high-speed camera has already been published in a peer-review journal. It is non-contact and measures lens movement. The test lasts less than 5 minutes.
Further research is required to assess the amount of lens oscillation (wobbling) in different eye populations - patients with previous cataract surgery (an artificial implant is used to replace the lens) or eye conditions (such as pseudoexfoliation, Marfan syndrome). The amount of lens stability has a role in the planning of further intraocular surgery - especially cataract extraction - however, at present, there is no approved quantitative measurement for this.
Participants will be recruited through Anglia Ruskin University (educational establishment), local community groups, and through Southend University Hospital eye clinics (NHS organisation). Participants' data will remain anonymous.
- Conditions
- Marfan's Syndrome With Ocular Manifestations, Pseudoexfoliation Syndrome, Cataract, Phakodonesis, Ectopia Lentis
- Medical subject headings
- Exfoliation Syndrome, Cataract, Ectopia Lentis
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 |
|---|---|---|
| Conditions with predisposition to lens oscillations | Marfan Syndrome and Pseudoexfoliation | |
| Age-matched with normal axial lengths | Not described | |
| Age-matched with extreme axial lengths | Not described | |
| Intraocular lens | Not described | |
| Pre- and post- cataract surgery | Not described | |
| Normals | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the feasibility of implementing a larger study
Criteria: number of eligible participants.This can then inform the sample size calculation for the larger study.
Measured: 1 year
Secondary outcomes (4)
Assessing lens oscillation amplitude in different patient populations using a non-invasive, high-speed camera
The measurement tool is a non-invasive, high-speed camera device that is used to assess lens oscillations has been made for this purpose by one of the co investigators. The device measures lens oscillations in a quantitative way, being much simpler and more accurate compared to previous qualitative assessments. The outcome measure, lens oscillation, is measured by: amplitude, which will be compared across the six patient population groups.
Measured: 1 year
Assessing lens oscillation ("wobbliness") by oscillation frequency in different patient populations using a non-invasive, high-speed camera
The measurement tool is a non-invasive, high-speed camera device that is used to assess lens oscillations has been made for this purpose by one of the co investigators. The device measures lens oscillations in a quantitative way, being much simpler and more accurate compared to previous qualitative assessments. The outcome measure, lens oscillation, is measured by: oscillation frequency, which will be compared across the six patient population groups.
Measured: 1 year
Assessing lens oscillation by damping ratio in different patient populations using a non-invasive, high-speed camera
The measurement tool is a non-invasive, high-speed camera device that is used to assess lens oscillations has been made for this purpose by one of the co investigators. The device measures lens oscillations in a quantitative way, being much simpler and more accurate compared to previous qualitative assessments. The outcome measure, lens oscillation, is measured by: damping ratio, which will be compared across the six patient population groups.
Measured: 1 year
Assessing lens oscillation by the stationary time in different patient populations using a non-invasive, high-speed camera
The measurement tool is a non-invasive, high-speed camera device that is used to assess lens oscillations has been made for this purpose by one of the co investigators. The device measures lens oscillations in a quantitative way, being much simpler and more accurate compared to previous qualitative assessments. The outcome measure, lens oscillation, is measured by: stationary time, which will be compared across the six patient population groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study startOct 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marfan's Syndrome With Ocular ManifestationsStudies 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
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anglia Ruskin University
- Sponsor type
- University, hospital or other
- Collaborators
- Mid and South Essex NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274634
- Sponsor's protocol ID
- OSCCIL
- Status last verified
- Jul 2020
- First submitted
- 3 Feb 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- 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 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oscillation of Crystalline and Intraocular Lenses: a Feasibility Study of the Lens' Movements in the Eye
- ClinicalTrials.gov ID
- NCT04274634
- Acronym / sponsor ID
- OSCCIL
- Conditions
- Marfan's Syndrome With Ocular Manifestations, Pseudoexfoliation Syndrome, Cataract, Phakodonesis, Ectopia Lentis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Anglia Ruskin UniversityUniversity, hospital or other
- Collaborators
- Mid and South Essex NHS Foundation Trust
- Study start
- Oct 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 18 Feb 2020 (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 crystalline lens of the human eye helps to sharpen vision. There can be issues with the support/stability of the lens. This could be seen with the naked eye of an external observer or with the use of a slit lamp.
Certain eye conditions can predispose to issues with lens stability. If patients have stability issues with their natural lens- this would be termed as "phakodonesis". However, in patients who have had prior cataract surgery with implantation of an artificial lens (IOL)- this would be termed as "pseudophakodonesis". Eye conditions such as pseudoexfoliation or Marfan-syndrome can lead to unstable lens support- this can be detected if there are advanced stability issues.
However, small instability in the eye's would not be detected with present descriptive methods. The authors have designed a high-speed camera which is able to detect stability of the lens, especially during eye movements. The high-speed camera can detect variation in the change of light reflex from the lens and calculate the amount of lens instability/oscillation. The results (in normal eyes) of this high-speed camera has already been published in a peer-review journal. It is non-contact and measures lens movement. The test lasts less than 5 minutes.
Further research is required to assess the amount of lens oscillation (wobbling) in different eye populations - patients with previous cataract surgery (an artificial implant is used to replace the lens) or eye conditions (such as pseudoexfoliation, Marfan syndrome). The amount of lens stability has a role in the planning of further intraocular surgery - especially cataract extraction - however, at present, there is no approved quantitative measurement for this.
Participants will be recruited through Anglia Ruskin University (educational establishment), local community groups, and through Southend University Hospital eye clinics (NHS organisation). Participants' data will remain anonymous.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Conditions with predisposition to lens oscillations | – | –Marfan Syndrome and Pseudoexfoliation |
| Age-matched with normal axial lengths | – | – |
| Age-matched with extreme axial lengths | – | – |
| Intraocular lens | – | – |
| Pre- and post- cataract surgery | – | – |
| Normals | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary care, community sample
Key inclusion criteria (2 listed)
- >18 years old
- Able to read and understand the English language
Key exclusion criteria (4 listed)
- Significant corneal scarring
- Taking medications that cause miosis (pupil constriction)
- Patients with no light perception
- Patients unable to open their eyes e.g. due to significant ptosis
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
Assess the feasibility of implementing a larger study
Time frame: 1 year
Criteria: number of eligible participants.This can then inform the sample size calculation for the larger study.
4 secondary outcomes
Assessing lens oscillation amplitude in different patient populations using a non-invasive, high-speed camera
Time frame: 1 year
Assessing lens oscillation ("wobbliness") by oscillation frequency in different patient populations using a non-invasive, high-speed camera
Time frame: 1 year
Assessing lens oscillation by damping ratio in different patient populations using a non-invasive, high-speed camera
Time frame: 1 year
Assessing lens oscillation by the stationary time in different patient populations using a non-invasive, high-speed camera
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- 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.
Southend University Hospital NHS Foundation Trust
Southend-on-Sea, United Kingdom
Vision and Eye Research Institute (VERI)
Cambridge, United Kingdom
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Marfan's Syndrome With Ocular Manifestations and Pseudoexfoliation Syndrome, run by Anglia Ruskin University at 2 sites in United Kingdom.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the feasibility of implementing a larger study (time frame: 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 29 Jul 2020.