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

NCT03531671 | Completed

• 1 other identifier: KEAP1003
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Post-Operative Measurements

  18 Months

• Post-Operative Measurements

  18 Months

• Post-Operative Measurements

  18 Months

Study Arms (1)

Presence of age related cataract

EXPERIMENTAL

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

Device: Binocular-OCT

Interventions

Binocular-OCT DEVICE

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

Presence of age related cataract

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Pearse Keane

  Moorfields Eye Hospital NHS Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: May 22, 2018
• Study Start: August 30, 2018
• Primary Completion: February 25, 2020
• Study Completion: November 17, 2020
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)