Comprehensive intermediate and near vision testing with trifocal intraocular lenses

Technology validation and optimization for Trifocal Intra Ocular Lens visual performance quantification

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43094282

Enrollment

Registered

2020-03-10

Start date

2019-02-01

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 pseudophakic patients implanted with trifocal IOLs Eye Diseases

Interventions

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

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® PanOptix (TFNT00) or RayOne Trifocal by Rayner or Fine Vision Trifocal by PhysIOL 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

Measure	Time frame
Intermediate and near 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 ten vision testing conditions with two different contrasts (high and low) and timed: 1. Best distance correction 2. Best distance correction & +0.50D spherical refractive blur 3. Best distance correction & -0.50D spherical refractive blur 4. Best distance correction & -1.00D cylinder axis 45	—

Measure

Time frame

Intermediate and near 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 ten vision testing conditions with two different contrasts (high and low) and timed: 1. Best distance correction 2. Best distance correction & +0.50D spherical refractive blur 3. Best distance correction & -0.50D spherical refractive blur 4. Best distance correction & -1.00D cylinder axis 45

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

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