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Comprehensive distance vision testing with monofocal intraocular lenses

Technology validation and optimization for Monofocal Intra Ocular Lens visual performance quantification.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN15794715
Enrollment
30
Registered
2020-03-04
Start date
2019-01-04
Completion date
Unknown
Last updated
2020-03-30

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

Conditions

Vision of pseudophakics subjects implanted with monofocal IOLs Eye Diseases

Interventions

Participants who have been implanted with monofocal IOLs will be wearing four different spectacle corrections at the clinic only (one study visit of approximately 4-5 hours). The investigator will exa

Sponsors

Ocular Technology Group International
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. At least 18 years of age 2. Have read and understood the Participant Information Sheet and gave Informed Consent 3. Pseudophakic successfully implanted with AcrySof® IQ Monofocal IOLs bilaterally for at least 3 months but no longer than 24 months 4. Best-corrected visual acuity of at least +0.20 logMAR (20/32) in each eye 5. 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 study participation 2. History of any ocular surgical procedures or surgeries other than cataract surgery including but not limited to limbal relaxing incision (LRI),astigmatic keratotomy, laser-assisted in situ keratomileusis (LASIK), and retinal laser treatment 3. Use of systemic or ocular medications that could be contraindicated as determined by the investigator 4. Any moderate or severe ocular condition observed during the slit-lamp examination prior to study vision measurements 5. Known pregnancy or lactation during the study period

Design outcomes

Primary

MeasureTime frame
Visual acuities in letters will be measured once using ETDRS charts (control) and OTGi vision suite (test) recorded in LogMAR with four corrections under the nine vision testing conditions with varying luminance (bright and dim), time and contrast (high and low) 1. Best distance correction 2. Best distance correction & +0.50D spherical refractive blur 3. Best distance correction & +1.00D spherical refractive blur 4. Best distance correction & -1.00D cylinder axis 45

Countries

United Kingdom

Outcome results

None listed

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