NCT03152500

Brief Summary

In this study the investigators will investigate the stability of lens position and the visual outcome after implantation of the new FEMTIS-IOL using FLACS capsulotomy compared to conventional placement of the IOL in the capsular bag. So far, there are no published studies using the FEMTIS-IOL. Therefore, the investigators will perform this randomized control trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

May 8, 2017

Last Update Submit

April 30, 2018

Conditions

Cataract

Keywords

IOLStabilityFEMTIS IOLAcrysof IOLFLACSCapsulotomy

Outcome Measures

Primary Outcomes (1)

  • Decentration:To compare the amount of decentration between FEMTIS IOL versus a standard monofocal IOL (Acrysof monofocal IOL) using retro-illumination slitlamp photographs

    To compare the amount of decentration between FEMTIS IOL versus a standard monofocal IOL (Acrysof monofocal IOL) using retro-illumination slitlamp photographs

    13 weeks/3months

Secondary Outcomes (3)

  • Rotation stability

    13 weeks/3months

  • Tilt: To compare the amount of tilt between both IOls using Scheimpflug images

    13 weeks/3months

  • Visual outcomes

    13 weeks/3months

Study Arms (2)

FEMTIS IOL

EXPERIMENTAL

The FEMTIS-IOL has a special haptic system that allows the lens to clamp into the capsulorrhexis.

Device: FEMTIS 313G IOL

Acrysof IOL

ACTIVE COMPARATOR

The Acrysof IOL has a flexible haptic design that keeps the IOL stable and centered in the capsular bag

Device: Acrysof SN60WF IOL

Interventions

FEMTIS 313G IOLDEVICE

Haptic design that enclaves the capsulorrhexis

FEMTIS IOL
Acrysof SN60WF IOLDEVICE

IOL in the bag

Acrysof IOL

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimum 40 years of age
  • Cataracta Senilis
  • Expected postoperative astigmatism ≤ 0.75 D (combination with FLACS AK is tolerated up to 1.25 D preoperative astigmatism)
  • IOL power calculation between +10.00 D and 27.00 D
  • Expected postoperative best-corrected visual acuity of logMAR +0.3 or better
  • If eligible, availability to undergo second eye surgery within 2 weeks of the first eye surgery
  • Willing and able to comply with scheduled visits and other study procedures
  • Signed informed consent.

You may not qualify if:

  • Traumatic cataract
  • Previous corneal surgery and/or reshaping
  • Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
  • Irregular astigmatism
  • History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
  • Extensive age related macular degeneration (atrophic or exudative age-related macular degeneration or numerous soft drusen)
  • Extensive visual field loss (e.g., glaucoma, history of cerebral vascular accidents, etc.)
  • Extensive diabetic macular disease
  • Amblyopia, strabismus
  • Keratoconus
  • Pseudoexfoliation syndrome or other capsule or zonular abnormalities that could affect postoperative centration or tilt of the IOL
  • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions)
  • Cognitive, cerebral or concentration disorders (e.g. dementia, Parkinson, etc.)
  • Suturing of incision required at time of surgery
  • Complications during surgery of the first eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Rudy Nuijts, MD PhD

    University Eye Clinic Maastricht, Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 15, 2017

Study Start

January 1, 2017

Primary Completion

September 30, 2017

Study Completion

October 30, 2017

Last Updated

May 2, 2018

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

No IPD will be shared

Locations

NL(1)