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The Oscillation of Crystalline and Intraocular Lenses

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ClinicalTrials.gov Identifier: NCT04274634
Recruitment Status : Not yet recruiting
First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
Southend University Hospital
Information provided by (Responsible Party):
Anglia Ruskin University

Brief 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. 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.


Condition or disease
Marfan's Syndrome With Ocular Manifestations Pseudoexfoliation Syndrome Cataract Phakodonesis Ectopia Lentis

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Oscillation of Crystalline and Intraocular Lenses: a Feasibility Study of the Lens' Movements in the Eye
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021


Group/Cohort
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Assessing lens oscillation amplitude in different patient populations using a non-invasive, high-speed camera [ Time Frame: 1 year ]
    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.

  2. Assessing lens oscillation ("wobbliness") by oscillation frequency in different patient populations using a non-invasive, high-speed camera [ Time Frame: 1 year ]
    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.

  3. Assessing lens oscillation by damping ratio in different patient populations using a non-invasive, high-speed camera [ Time Frame: 1 year ]
    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.

  4. Assessing lens oscillation by the stationary time in different patient populations using a non-invasive, high-speed camera [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Secondary care, community sample
Criteria

Inclusion Criteria:

  • >18 years old
  • Able to read and understand the English language

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04274634


Locations
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United Kingdom
Southend University Hospital NHS Foundation Trust
Southend-on-Sea, Essex, United Kingdom, SS0 0RY
Contact: Craig Mackerness    01702 385089    craig.mackerness@southend.nhs.uk   
Contact: Aman Chandra       aman.chandra@southend.nhs.uk   
Vision and Eye Research Institute (VERI)
Cambridge, United Kingdom, CB1 2LZ
Contact: Megan H Vaughan    01223695310    megan.vaughan@pgr.anglia.ac.uk   
Contact: Shahina Pardhan         
Sponsors and Collaborators
Anglia Ruskin University
Southend University Hospital

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Responsible Party: Anglia Ruskin University
ClinicalTrials.gov Identifier: NCT04274634    
Other Study ID Numbers: OSCCIL
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marfan Syndrome
Arachnodactyly
Cataract
Exfoliation Syndrome
Ectopia Lentis
Syndrome
Disease
Pathologic Processes
Lens Diseases
Eye Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Connective Tissue Diseases
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Iris Diseases
Uveal Diseases
Eye Abnormalities
Lens Subluxation