Assessing the Optics of the Eye Pre- and Post-operatively in Cataract

Study Overview
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Brief Summary
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The purpose of the study is to investigate if a novel instrument called a Binocular Optical Coherence Tomographer (OCT) may resolve many of the issues with the assessment of patients with cataract.

Detailed Description
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Cataract is the second leading cause of blindness in western Europe but the leading cause of blindness in the developing world and both central and eastern Europe. The most common cause of cataract is age. A number of clinical assessments are required to assess the status and suitability of each patient for cataract surgery. Currently, these procedures are performed in an inefficient manner with the patient having to move to different clinical areas to access often large instruments that are costly to both purchase and maintain. Such an inefficient patient pathway has been identified as a factor that can markedly increase the cost of outpatient appointments, extend waiting times, and crucially lead to a reduction in patient satisfaction. A novel instrument that offers a solution to such problems is the recently developed Binocular Optical Coherence Tomographer. Binocular-OCT is capable of non-invasively imaging the whole-eye in a potentially small, inexpensive and portable device and is also capable of capturing images from both eyes in the same session without the need for assistance from a trained technician. The Binocular-OCT has the capability to perform the functions of many clinical tools in a single instrument. Of particular relevance to the assessment of the patient with cataract is the ability to capture high resolution images of the anterior eye and crystalline lens with swept-source OCT technology. In this study, the proposed advantages of binocular OCT system will be assessed for the management of cataract. This research is important, to not only improve cataract assessment and optomise surgical outcomes, but it is also vital to establish sensitive measures of lens quality to determine tools to aid trails attempting to retard the progression of cataract.

Official Title
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The Future of Cataract Assessment: Investigation of the Utility of a Novel Binocular OCT System for Clinical Application

Conditions
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Cataract

Intervention / Treatment
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* Device: Binocular-OCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Presence of cataract Male or female, aged 18 years or older Ability to understand nature/purpose of the study and to provide informed consent Ability to undergo binocular OCT imaging Ability to follow instructions and complete the study Ability to speak English Exclusion Criteria: - Hearing impairment sufficient to interfere with hearing instructions Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct. Any cases where the globe has been affected by trauma, etc. Traumatic aetiologies of cataract

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Assessing age related cataract, all 200 subjects will have whole eye OCT scan performed during their pre-operative cataract assessment and 50 subjects (all subjects requested to participate until 50 subject criteria met) will have these assessments reassessed during their post-operative assessment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Presence of age related cataract<br>Binocular-OCT used to assess the eye pre and post-operatively. | Device: Binocular-OCT<br>* Binocular Optical Coherence Tomographer used to assess both eyes in the same session without the need for a trained assistant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Investigate the feasibility of the Binocular-OCT to produce accurate biometric measurements of the eye, via calculation of quantitative cataract density and localisation index from the binocular-OCT image of the lens. | 18 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Operative Measurements | Examining the ability of the Binocular-OCT to perform post-operative assessments of the lens position. | 18 Months | 
| Post-Operative Measurements | Examining the ability of the Binocular-OCT to perform post-operative assessments of the ocular clarity. | 18 Months | 
| Post-Operative Measurements | Examining the ability of the Binocular-OCT to perform post-operative assessments of the retinal thickness. | 18 Months |