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

NCT ID: NCT03390400

Last Updated: 2018-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-29

Study Completion Date

2018-03-14

Brief Summary

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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

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Conditions

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Age Related Cataracts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

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Anterior Capsulotomy before Lens Fragmentation

Anterior capsulotomy will be performed by femtosecond laser before lens fragmentation

Group Type ACTIVE_COMPARATOR

Femtosecondlaser-assisted

Intervention Type DEVICE

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

Anterior Capsulotomy

Intervention Type PROCEDURE

Cataract Surgery

Lens Fragmentation before Anterior Capsulotomy

Lens fragmentation will be performed by femtosecond laser before anterior capsulotomy

Group Type ACTIVE_COMPARATOR

Femtosecondlaser-assisted

Intervention Type DEVICE

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

Lens Fragmentation

Intervention Type PROCEDURE

Cataract Surgery

Interventions

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Femtosecondlaser-assisted

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

Intervention Type DEVICE

Anterior Capsulotomy

Cataract Surgery

Intervention Type PROCEDURE

Lens Fragmentation

Cataract Surgery

Intervention Type PROCEDURE

Other Intervention Names

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Laser assisted Cataract Surgery

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rupert Menapace

OTHER

Sponsor Role lead

Responsible Party

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Rupert Menapace

Prof. Dr. med. univ.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rupert Menapace, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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Femto-PGII Study

Identifier Type: -

Identifier Source: org_study_id

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