Assessing the Optics of the Eye Pre- and Post-operatively in Cataract (CAT)
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Binocular-OCT
Sponsored by
About this trial
This is an interventional device feasibility trial for Cataract
Eligibility Criteria
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
Sites / Locations
- Moorfields Eye Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Presence of age related cataract
Arm Description
Binocular-OCT used to assess the eye pre and post-operatively.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Post-Operative Measurements
Examining the ability of the Binocular-OCT to perform post-operative assessments of the lens position.
Post-Operative Measurements
Examining the ability of the Binocular-OCT to perform post-operative assessments of the ocular clarity.
Post-Operative Measurements
Examining the ability of the Binocular-OCT to perform post-operative assessments of the retinal thickness.
Full Information
NCT ID
NCT03531671
First Posted
March 13, 2018
Last Updated
February 26, 2021
Sponsor
Moorfields Eye Hospital NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03531671
Brief Title
Assessing the Optics of the Eye Pre- and Post-operatively in Cataract
Acronym
CAT
Official Title
The Future of Cataract Assessment: Investigation of the Utility of a Novel Binocular OCT System for Clinical Application
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
November 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moorfields Eye Hospital NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Presence of age related cataract
Arm Type
Experimental
Arm Description
Binocular-OCT used to assess the eye pre and post-operatively.
Intervention Type
Device
Intervention Name(s)
Binocular-OCT
Intervention Description
Binocular Optical Coherence Tomographer used to assess both eyes in the same session without the need for a trained assistant.
Primary Outcome Measure Information:
Title
Feasibility
Description
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.
Time Frame
18 Months
Secondary Outcome Measure Information:
Title
Post-Operative Measurements
Description
Examining the ability of the Binocular-OCT to perform post-operative assessments of the lens position.
Time Frame
18 Months
Title
Post-Operative Measurements
Description
Examining the ability of the Binocular-OCT to perform post-operative assessments of the ocular clarity.
Time Frame
18 Months
Title
Post-Operative Measurements
Description
Examining the ability of the Binocular-OCT to perform post-operative assessments of the retinal thickness.
Time Frame
18 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pearse Keane
Organizational Affiliation
Moorfields Eye Hospital NHS Foundation Trust
Official's Role
Study Director
Facility Information:
Facility Name
Moorfields Eye Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data retained within the central research team.
Learn more about this trial
Assessing the Optics of the Eye Pre- and Post-operatively in Cataract
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