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

Cataract Clinical Trial

— CAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531671
• Other study ID #: KEAP1003
• Status: Completed
• Phase: N/A
• Start date: August 30, 2018
• Est. completion date: November 17, 2020

Study information

• Verified date: February 2021
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 17, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Binocular-OCT
Binocular Optical Coherence Tomographer used to assess both eyes in the same session without the need for a trained assistant.

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-Operative Measurements	Examining the ability of the Binocular-OCT to perform post-operative assessments of the lens position.	18 Months
Secondary	Post-Operative Measurements	Examining the ability of the Binocular-OCT to perform post-operative assessments of the ocular clarity.	18 Months
Secondary	Post-Operative Measurements	Examining the ability of the Binocular-OCT to perform post-operative assessments of the retinal thickness.	18 Months