A randomised, subject-masked evaluation of introcular lens stability after implantation of two different lens models: FEMTIS-study

A randomised, subject-masked evaluation of introcular lens stability after implantation of two different lens models: FEMTIS-study - FEMTIS-study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42905

Enrollment

Registered

2016-11-18

Start date

2017-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Cataract clouding of the lens in the eye

Interventions

Cataract surgery with implantatie of either a FEMTIS-IOL or an Acrysof Monofocal IOL

Cataract

Intraocular lenses

Stability

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Cataract Minimum 40 years of age Astigmatism

Exclusion criteria

Exclusion criteria: Traumatic cataract Corneal diseases/surgery Extensive eye diseases, e.g. macular degeneration, glaucoma, diabetic macular disease Amblyopia Cognitive, cerebral or concentration disorders

Design outcomes

Primary

Measure	Time frame
Mean postoperative decentration at 13 weeks postoperatively	—

Secondary

Measure	Time frame
- Mean rotation at 13 weeks postoperatively - Mean tilt 13 weeks postoperatively - Mean subjective refraction 13 weeks postoperatively - Mean uncorrected distance visual acuity (UDVA) 13 weeks postoperatively - Mean best corrected distance visual acuity (BCVA) 13 weeks postoperatively - Complication profile 13 weeks postoperatively	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)