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Clinical Trials/NCT03531671
NCT03531671CompletedNot Applicable

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

Moorfields Eye Hospital NHS Foundation Trust1 site in 1 country22 target enrollmentStarted: August 30, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
Feasibility

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Presence of age related cataract

Experimental

Binocular-OCT used to assess the eye pre and post-operatively.

Intervention: Binocular-OCT (Device)

Outcomes

Primary Outcomes

Feasibility

Time Frame: 18 Months

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 Outcomes

  • Post-Operative Measurements(18 Months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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