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OpenTrials
Completed

NCT Number: NCT03531671

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Binocular-OCT

Device

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

Primary outcomes

  1. 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

  1. Post-Operative Measurements

    Time frame: 18 Months

    Examining the ability of the Binocular-OCT to perform post-operative assessments of the lens position.

  2. Post-Operative Measurements

    Time frame: 18 Months

    Examining the ability of the Binocular-OCT to perform post-operative assessments of the ocular clarity.

  3. Post-Operative Measurements

    Time frame: 18 Months

    Examining the ability of the Binocular-OCT to perform post-operative assessments of the retinal thickness.

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: CAT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 22, 2018
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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