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Study to validate a new test to measure contrast vision

Letter contrast sensitivity testing in a young presbyopic phakic population

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87623837
Enrollment
20
Registered
2021-01-29
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluation of contrast sensitivity testing methods in a presbyopic phakic population Eye Diseases Presbyopia

Interventions

Sponsors

Ocular Technology Group - International
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 40-50 years 2. Spectacle refraction: Distance: Sphere: -6.00D to +4.00D, Astigmatism: 0.00D to -3.00D, Near Addition: +0.50D to +2.50D 3. Best corrected visual acuity of at least 20/20 in each eye 4. Spectacles or soft contact lenses habitual visual correction 5. Have normal eyes with the exception of a need for visual correction 6. Have read and understood the Participant Information Sheet in English 7. Have read, signed and dated the Informed Consent 8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

Exclusion criteria

Exclusion criteria: 1. Ocular anterior segment infection, inflammation, abnormality or active disease that would contraindicate contact lens wear 2. Newly prescribed (within past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilisers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eye drops which is not rewetting eyedrops for which contact lens wear would be contraindicated as determined by the investigator 3. Monocular patients (only one eye with functional vision) or participants fit with only one lens 4. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit 5. History of herpetic keratitis, ocular surgery or irregular cornea 6. Known pregnancy during the study period 7. Enrollment of the investigator or his/her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals

Design outcomes

Primary

MeasureTime frame
Contrast sensitivity measured at photopic (85 cd/m²) and mesopic (2.5 cd/m²) light levels at up to five spatial frequencies: 18, 12, 6, 3 and 1.5 c/degree using: 1. OTG-i Vision Suite letter contrast sensitivity test 2. M&S Technologies linear sine wave grating test from the Clinical Trial Suite 3. Vector Vision standardized contrast sensitivity Measured twice up to 1 week apart

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

United Kingdom

Contacts

Public ContactDeborah Moore
dmoore@otg.co.uk+44 (0)2072224224

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026