NCT03465124

Brief Summary

The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery. Cataract surgery will be performed in subjects who have signed an informed consent form. Macula thickness will be measured with Spectralis OCT on screening date. Postoperative examinations will be implemented in accordance with the approved investigational plan on subjects and includes: visual acuity, slitlamp examination, retinal oct imaging and quantitative autofluorescence.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 1, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

March 26, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2019

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

March 1, 2018

Last Update Submit

March 6, 2019

Conditions

Age Related CataractsCystoid Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Central Macular Thickness

    Difference in Central Macular Thickness (CMT) between Femtosecond Laser-assisted Cataract Surgery (LCS) to Manual Cataract Surgery (MCS)

    Baseline to 6 weeks postoperative

Secondary Outcomes (2)

  • Influence of lens density on quantitative autofluorescence

    Baseline to 1 weel, 3 weeks and 6 weeks postoperative

  • Central Macular Thickness

    Baseline to 1 week, 3 weeks, 6 weeks postoperative

Study Arms (2)

Femtosecond Laser assisted Cataract Surgery

ACTIVE COMPARATOR

Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order.

Device: Femtosecond Laser

Manual Cataract Surgery

ACTIVE COMPARATOR

Manual Cataract Surgery will be performed in contralateral (to LCS) eye of patient with bilateral age-related cataract.

Other: Manual Cataract Surgery

Interventions

Femtosecond LaserDEVICE

Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. Contralateral eye will receive conventional cataract surgery

Femtosecond Laser assisted Cataract Surgery
Manual Cataract SurgeryOTHER

conventional cataract surgery as control

Manual Cataract Surgery

Eligibility Criteria

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

You may qualify if:

  • Bilateral Age-related cataract necessitating lens extraction and posterior IOL implantation
  • Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)

You may not qualify if:

  • Corneal abnormality
  • Preceding ocular surgery or trauma
  • Uncontrolled glaucoma
  • Proliferative diabetic retinopathy
  • Macular degeneration
  • Iris neovascularization
  • History of uveitis/iritis
  • Microphthalmus
  • Recurrent intraocular inflammation of unknown etiology
  • Blind fellow eye
  • Uncontrolled systemic or ocular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • Reiter GS, Schwarzenbacher L, Schartmuller D, Roggla V, Leydolt C, Menapace R, Schmidt-Erfurth U, Sacu S. Influence of lens opacities and cataract severity on quantitative fundus autofluorescence as a secondary outcome of a randomized clinical trial. Sci Rep. 2021 Jun 16;11(1):12685. doi: 10.1038/s41598-021-92309-6.

    PMID: 34135449DERIVED

MeSH Terms

Conditions

Macular Edema

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Rupert Menapace, MD

    Medical Universitiy of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Groups will be randomized. Randomization information will be put in a sealed envelope on screening date and opened in operating theatre right before procedure start.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Bilateral cataract surgery will be performed in individuals with age-related cataract. Eyes will be randomized into two groups receiving either Femtosecond Laser assisted Cataract Surgery (LCS) or conventional Manual Cataract Surgery (MCS).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 14, 2018

Study Start

March 26, 2018

Primary Completion

February 19, 2019

Study Completion

April 6, 2019

Last Updated

March 7, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)