Clinical trial NCT04274634: The Oscillation of Crystalline and Intraocular Lenses
Official title: The Oscillation of Crystalline and Intraocular Lenses: a Feasibility Study of the Lens' Movements in the Eye
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Marfan's Syndrome With Ocular Manifestations
Pseudoexfoliation Syndrome
Cataract
Phakodonesis
Ectopia Lentis
Lead sponsor: Anglia Ruskin University
Sponsor class: OTHER
Collaborators: name: Mid and South Essex NHS Foundation Trust
First posted: 2020-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Secondary care, community sample

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.


Eligibility 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

Primary outcomes:
measure: Assess the feasibility of implementing a larger study
timeFrame: 1 year
Secondary outcomes:
measure: Assessing lens oscillation amplitude in different patient populations using a non-invasive, high-speed camera
timeFrame: 1 year
measure: Assessing lens oscillation ("wobbliness") by oscillation frequency in different patient populations using a non-invasive, high-speed camera
timeFrame: 1 year
measure: Assessing lens oscillation by damping ratio in different patient populations using a non-invasive, high-speed camera
timeFrame: 1 year
measure: Assessing lens oscillation by the stationary time in different patient populations using a non-invasive, high-speed camera
timeFrame: 1 year
Other outcomes:
Locations:
city: Southend-on-Sea
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust
state: Essex
city: Cambridge
country: United Kingdom
facility: Vision and Eye Research Institute (VERI)
Study officials:
References: