Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06224751
Other study ID # 277317
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 2024
Est. completion date January 2025

Study information

Verified date March 2024
Source Guy's and St Thomas' NHS Foundation Trust
Contact Abigail Orr, BSc
Phone 020 7188 4885
Email eyeresearch@gstt.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Clinical vision measurements usually involve printed charts with an eye care professional interpreting patient responses to generate a score. Those scores determine the need for or outcome of treatment. Detecting change can be improved with strict procedures/scoring, lending itself to computerisation. This in turn allows integration with electronic medical records. Many eye tests could be computerised in this way. At Guys and St Thomas' NHS Foundation Trust, the investigators have developed and validated a computerised test of distance visual acuity, called COMPlog which is now in widespread use. The investigators now want to increase the range of tests available. There is also a need to longitudinally monitor for adverse change. Such monitoring must be developed to keep false positive and false negative change detection to a minimum. The aims of this two year linked program are to: Part A) validate an extended range of computerised vision measurement tests against their gold standard hard copy printed equivalents. Some of these tests are designed for use in children and all are meant to quantify both normal and impaired vision. Patients of all ages and visual function will therefore be recruited from St Thomas' Hospital. The specific tests we aim to validate are logMAR Letter Near Acuity, Word Near Acuity, Letter Contrast Sensitivity, Auckland Optotypes Picture Acuity, Low Contrast Letter Acuity, Stereoacuity and Vanishing Optotypes. Patients will undergo test-retest measurements with up to two of these. Part B) Iteratively develop an application for use in home monitoring of subjects at risk of treatable vision loss due to age related macular degeneration. All computerised tests in parts A and B will be performed on prototype software. Eye patients will be recruited as subjects. Patients recruited to part A will undergo tests on one day for up to an hour, subjects in part B will participate for between 1 hour and two months.


Recruitment information / eligibility

Status Recruiting
Enrollment 550
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 99 Years
Eligibility Inclusion Criteria: - Male and female patients attending hospital eye clinics, aged 3 - 99, inclusive. - Patients able to understand the information sheet, and willing and able to give informed consent to participate. - Patients with visual function ranging from normal to severely impaired. - Willing and able to comply with the visual function testing protocol. - Some validation studies require recruitment of disease specific groups (such as children with amblyopia or adults with age related macular degeneration). For Part B of the project which aims to develop and pilot a home monitoring application, only adult (18-99 years) subjects complying with the above who also own a suitable browser device will be recruited. Exclusion Criteria: - Unwilling or unable to comply with the visual function testing protocol. - Unwilling or unable to give informed consent. - Unwilling to participate. - In other research trials.

Study Design


Intervention

Diagnostic Test:
Near logMAR letter acuity
Comparison of gold standard printed tests and computerised versions
Near LogMAR word acuity
Comparison of gold standard printed tests and computerised versions
Red Green Stereoacuity
Comparison of gold standard printed tests and computerised versions
Auckland Optotype/Auckland Vanishing Optotypes
Comparison of gold standard printed tests and computerised versions
Vanishing Optotype Sloan Letters
Comparison of gold standard printed tests and computerised versions
Letter Contrast Sensitivity
Comparison of gold standard printed tests and computerised versions
Low Contrast Letter Acuity
Comparison of gold standard printed tests and computerised versions

Locations

Country Name City State
United Kingdom St Thomas' Hospital NHS Foundation Trust London

Sponsors (2)

Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Test agreement between the computerised vision measurement test and the gold standard hard copy test. The test agreement is quantified in terms of the mean difference and 95% confidence interval of the mean in log units. Through study completion, an average of 1 year
Primary Test-retest variability for the computerised vision measurement test and the gold standard hard copy test. Measurement variability (difference in two measures captured using the same vision test on the same day) will be quantified in log units for each vision test used in this study. Through study completion, an average of 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT06262737 - Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
Completed NCT02540954 - Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD) Phase 3
Completed NCT00385333 - Metabolic Mapping to Measure Retinal Metabolism Phase 2
Completed NCT02510794 - Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration Phase 2
Completed NCT02181504 - A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration Phase 2
Terminated NCT02228304 - Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD) Phase 1/Phase 2
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Recruiting NCT01521065 - An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Phase 2
Completed NCT01204541 - A Single-Center Pilot Study to Assess Macular Function N/A
Completed NCT00769392 - Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection N/A
Completed NCT00533520 - Evaluation of Dosing Interval of Higher Doses of Ranibizumab Phase 4
Withdrawn NCT00538538 - Subretinal Lucentis for Hemorrhagic Age-related Macular Degeneration (AMD) Phase 1
Completed NCT00536016 - A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD Phase 1
Terminated NCT00403442 - Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD Phase 1
Recruiting NCT00157976 - Double-Masked Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Age-Related Macular Degeneration Phase 3
Completed NCT00211458 - Treatment of Age-Related Macular Degeneration With Anecortave Acetate Phase 2
Completed NCT00239928 - Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration Phase 2
Completed NCT00242580 - A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib Phase 3
Completed NCT00095433 - Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD) Phase 3
Completed NCT00006202 - Lutein for Age-Related Macular Degeneration Phase 2