Clinical trial NCT03531671: Assessing the Optics of the Eye Pre- and Post-operatively in Cataract
Official title: The Future of Cataract Assessment: Investigation of the Utility of a Novel Binocular OCT System for Clinical Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Feasibility
timeFrame: 18 Months
Secondary outcomes:
measure: Post-Operative Measurements
timeFrame: 18 Months
measure: Post-Operative Measurements
timeFrame: 18 Months
measure: Post-Operative Measurements
timeFrame: 18 Months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
Study officials:
affiliation: Moorfields Eye Hospital NHS Foundation Trust
name: Pearse Keane
role: STUDY_DIRECTOR
References: