The Oscillation of Crystalline and Intraocular Lenses

Cataract Clinical Trial

Official title:

The Oscillation of Crystalline and Intraocular Lenses: a Feasibility Study of the Lens' Movements in the Eye

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04274634
• Other study ID #: OSCCIL
• Status: Not yet recruiting
• Start date: October 2020
• Est. completion date: March 2021

Study information

• Verified date: July 2020
• Source: Anglia Ruskin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United Kingdom	Vision and Eye Research Institute (VERI)	Cambridge
United Kingdom	Southend University Hospital NHS Foundation Trust	Southend-on-Sea	Essex

Sponsors (2)

Lead Sponsor	Collaborator
Anglia Ruskin University	Southend University Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year