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Sponsor study identifier
observational
50
1 country
2
Study Start
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 2021
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Study Completion
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2021
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 3, 2020
Actual (reported)February 18, 2020
Actual (reported)October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
1 year
Assessing lens oscillation amplitude in different patient populations using a non-invasive, high-speed camera
1 year
Assessing lens oscillation ("wobbliness") by oscillation frequency in different patient populations using a non-invasive, high-speed camera
1 year
Marfan Syndrome and Pseudoexfoliation
Secondary care, community sample
Southend University Hospital NHS Foundation Trust
Southend-on-Sea, Essex, SS0 0RY, United Kingdom
Vision and Eye Research Institute (VERI)
Cambridge, CB1 2LZ, United Kingdom
First Submitted
February 3, 2020
First Posted
February 18, 2020
Study Start
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 2021
Estimated (date passed)Assessing lens oscillation by damping ratio in different patient populations using a non-invasive, high-speed camera
1 year
Assessing lens oscillation by the stationary time in different patient populations using a non-invasive, high-speed camera
1 year
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 29, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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