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

March 1, 2018 updated by: Rupert Menapace

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total-Prostaglandin and PGE2 level in aqueous humor
Time Frame: 5 minutes after laser procedure (LCS)
pg/mL
5 minutes after laser procedure (LCS)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pupilsize
Time Frame: baseline, immediately after laser, 5 min after laser
in mm
baseline, immediately after laser, 5 min after laser

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rupert Menapace

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2017

Primary Completion (Actual)

January 2, 2018

Study Completion (Anticipated)

March 14, 2018

Study Registration Dates

First Submitted

December 28, 2017

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Femto-PGII Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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