Changes in Prostaglandin Levels in Laser Cataract Surgery... | NCT03390400

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

NCT03390400

Sponsor

Rupert Menapace

Status

Unknown status

Last Update Posted

Mar 2, 2018Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Age Related Cataracts

Interventions

Femtosecondlaser-assisted
Anterior Capsulotomy
Lens Fragmentation

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 29, 2017Actual

Primary Completion Date

Jan 2, 2018Actual

Completion Date

Mar 14, 2018Estimated

First Submitted Date

Dec 28, 2017

First Submission Date that Met QC Criteria

Jan 3, 2018

First Posted Date

Jan 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2018

Last Update Posted Date

Mar 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anterior Capsulotomy before Lens Fragmentation	Active Comparator	Anterior capsulotomy will be performed by femtosecond laser before lens fragmentation	Device: Femtosecondlaser-assisted Procedure: Anterior Capsulotomy
Lens Fragmentation before Anterior Capsulotomy	Active Comparator	Lens fragmentation will be performed by femtosecond laser before anterior capsulotomy	Device: Femtosecondlaser-assisted Procedure: Lens Fragmentation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Femtosecondlaser-assisted	Device	Femtosecondlaser-assisted Cataract Surgery will be performed bilateral on the same day with different laser settings.	Anterior Capsulotomy before Lens Fragmentation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rupert Menapace, MD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna		Vienna		1090	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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.

Masking Info

Masking

Triple

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.

Who Masked

ParticipantCare ProviderInvestigator