Clincosm LogoSign in Get a demo

Femto-PG: Changes in Prostaglandin Levels in Laser Cataract Surgery (LCS) Subject to Laser Prevalence

Sponsor
Rupert Menapace (Other)
Overall Status
Unknown status
CT.gov ID
NCT03390400
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
9.5
Anticipated Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Femtosecondlaser-assisted
  • Procedure: Anterior Capsulotomy
  • Procedure: Lens Fragmentation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Intraindividual Comparison of Prostaglandin E2 (PGE2) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Using a Low-energy, High-frequency Femtosecond Laser-Device in Regard to the Sequence of Anterior Capsulotomy and Lens Fragmentation
Actual Study Start Date :
May 29, 2017
Actual Primary Completion Date :
Jan 2, 2018
Anticipated Study Completion Date :
Mar 14, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Anterior Capsulotomy before Lens Fragmentation

Anterior capsulotomy will be performed by femtosecond laser before lens fragmentation

Device: Femtosecondlaser-assisted
Femtosecondlaser-assisted Cataract Surgery will be performed bilateral on the same day with different laser settings.
Other Names:
  • Laser assisted Cataract Surgery

    • Procedure: Anterior Capsulotomy
    Cataract Surgery
    Active Comparator: Lens Fragmentation before Anterior Capsulotomy

    Lens fragmentation will be performed by femtosecond laser before anterior capsulotomy

    Device: Femtosecondlaser-assisted
    Femtosecondlaser-assisted Cataract Surgery will be performed bilateral on the same day with different laser settings.
    Other Names:
  • Laser assisted Cataract Surgery

    • Procedure: Lens Fragmentation
    Cataract Surgery

    Outcome Measures

    Primary Outcome Measures

    1. Total-Prostaglandin and PGE2 level in aqueous humor [5 minutes after laser procedure (LCS)]

      pg/mL

    Secondary Outcome Measures

    1. Change in Pupilsize [baseline, immediately after laser, 5 min after laser]

      in mm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Vienna Vienna Austria 1090

    Sponsors and Collaborators

    • Rupert Menapace

    Investigators

    • Principal Investigator: Rupert Menapace, MD, Medical University of Vienna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rupert Menapace, Prof. Dr. med. univ., Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT03390400
    Other Study ID Numbers:
    • Femto-PGII Study
    First Posted:
    Jan 4, 2018
    Last Update Posted:
    Mar 2, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rupert Menapace, Prof. Dr. med. univ., Medical University of Vienna
    Laser Cataract Surgery
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Mar 2, 2018