NCT03390400

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. Aqueous humor will be collected and screening will be performed for Total Prostaglandin and Prostaglandin E2 via en-bloc Enzyme-linked Immunosorbent Assay (ELISA)-Kit.

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
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2017

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2018

Completed
Last Updated

March 2, 2018

Status Verified

March 1, 2018

Enrollment Period

7 months

First QC Date

December 28, 2017

Last Update Submit

March 1, 2018

Conditions

Age Related Cataracts

Keywords

Laser Cataract Surgery

Outcome Measures

Primary Outcomes (1)

  • Total-Prostaglandin and PGE2 level in aqueous humor

    pg/mL

    5 minutes after laser procedure (LCS)

Secondary Outcomes (1)

  • Change in Pupilsize

    baseline, immediately after laser, 5 min after laser

Study Arms (2)

Anterior Capsulotomy before Lens Fragmentation

ACTIVE COMPARATOR

Anterior capsulotomy will be performed by femtosecond laser before lens fragmentation

Device: Femtosecondlaser-assistedProcedure: Anterior Capsulotomy

Lens Fragmentation before Anterior Capsulotomy

ACTIVE COMPARATOR

Lens fragmentation will be performed by femtosecond laser before anterior capsulotomy

Device: Femtosecondlaser-assistedProcedure: Lens Fragmentation

Interventions

Femtosecondlaser-assistedDEVICE

Femtosecondlaser-assisted Cataract Surgery will be performed bilateral on the same day with different laser settings.

Also known as: Laser assisted Cataract Surgery
Anterior Capsulotomy before Lens FragmentationLens Fragmentation before Anterior Capsulotomy
Anterior CapsulotomyPROCEDURE

Cataract Surgery

Anterior Capsulotomy before Lens Fragmentation
Lens FragmentationPROCEDURE

Cataract Surgery

Lens Fragmentation before Anterior Capsulotomy

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation
  • Age: 40 to 90 (females of childbearing age will be interviewed if pregnancy is possible)
  • Preoperative pupil dilation in mydriasis ≥ 6.5 mm

You may not qualify if:

  • Preceding ocular surgery or trauma
  • Recurrent intraocular inflammation of unknown etiology
  • Uncontrolled glaucoma
  • Uncontrolled systemic or ocular disease
  • Blind fellow eye
  • Microphthalmus
  • Corneal abnormality
  • History of uveitis/iritis
  • Iris neovascularization
  • Pseudoexfoliation
  • Proliferative diabetic retinopathy
  • Pregnancy
  • Lactation
  • Females of childbearing age: not included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Study Officials

  • Rupert Menapace, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
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
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Bilateral femtosecond-laser assisted cataract surgery will be performed in individuals with age-related cataract. Eyes will be randomized into two groups receiving either anterior capsulotomy before lens fragmentation or vice versa in the contralateral eye. After laser procedure samples of aqueous humor will be collected and when complete all samples will be analysed by ELISA for Prostaglandin.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med. univ.

Study Record Dates

First Submitted

December 28, 2017

First Posted

January 4, 2018

Study Start

May 29, 2017

Primary Completion

January 2, 2018

Study Completion

March 14, 2018

Last Updated

March 2, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)