The Oscillation of Crystalline and Intraocular Lenses

NCT04274634 | Unknown

• 1 other identifier: OSCCIL
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Marfan's Syndrome With Ocular Manifestations; Pseudoexfoliation Syndrome; Cataract; Phakodonesis; Ectopia Lentis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

Study Arms (6)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Secondary care, community sample

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anglia Ruskin University: lead
• Mid and South Essex NHS Foundation Trust: collaborator

Study Sites (2)

Southend University Hospital NHS Foundation Trust

Southend-on-Sea, Essex, SS0 0RY, United Kingdom

Location

Vision and Eye Research Institute (VERI)

Cambridge, CB1 2LZ, United Kingdom

Location

MeSH Terms

Conditions

Exfoliation Syndrome; Cataract; Ectopia Lentis

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases; Lens Diseases; Eye Abnormalities; Lens Subluxation; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 18, 2020
• Study Start: October 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

GB (2)