search
Back to results

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

Primary Purpose

Age Related Cataracts

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Femtosecondlaser-assisted
Anterior Capsulotomy
Lens Fragmentation
Sponsored by
Rupert Menapace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Cataracts focused on measuring Laser Cataract Surgery

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Anterior Capsulotomy before Lens Fragmentation

Lens Fragmentation before Anterior Capsulotomy

Arm Description

Anterior capsulotomy will be performed by femtosecond laser before lens fragmentation

Lens fragmentation will be performed by femtosecond laser before anterior capsulotomy

Outcomes

Primary Outcome Measures

Total-Prostaglandin and PGE2 level in aqueous humor
pg/mL

Secondary Outcome Measures

Change in Pupilsize
in mm

Full Information

First Posted
December 28, 2017
Last Updated
March 1, 2018
Sponsor
Rupert Menapace
search

1. Study Identification

Unique Protocol Identification Number
NCT03390400
Brief Title
Changes in Prostaglandin Levels in Laser Cataract Surgery (LCS) Subject to Laser Prevalence
Acronym
Femto-PG
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 29, 2017 (Actual)
Primary Completion Date
January 2, 2018 (Actual)
Study Completion Date
March 14, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rupert Menapace

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Cataracts
Keywords
Laser Cataract Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anterior Capsulotomy before Lens Fragmentation
Arm Type
Active Comparator
Arm Description
Anterior capsulotomy will be performed by femtosecond laser before lens fragmentation
Arm Title
Lens Fragmentation before Anterior Capsulotomy
Arm Type
Active Comparator
Arm Description
Lens fragmentation will be performed by femtosecond laser before anterior capsulotomy
Intervention Type
Device
Intervention Name(s)
Femtosecondlaser-assisted
Other Intervention Name(s)
Laser assisted Cataract Surgery
Intervention Description
Femtosecondlaser-assisted Cataract Surgery will be performed bilateral on the same day with different laser settings.
Intervention Type
Procedure
Intervention Name(s)
Anterior Capsulotomy
Intervention Description
Cataract Surgery
Intervention Type
Procedure
Intervention Name(s)
Lens Fragmentation
Intervention Description
Cataract Surgery
Primary Outcome Measure Information:
Title
Total-Prostaglandin and PGE2 level in aqueous humor
Description
pg/mL
Time Frame
5 minutes after laser procedure (LCS)
Secondary Outcome Measure Information:
Title
Change in Pupilsize
Description
in mm
Time Frame
baseline, immediately after laser, 5 min after laser

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupert Menapace, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs