Microincision Versus Smallincision Combined Surgery

NCT ID: NCT01198483

Last Updated: 2016-09-07

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2018-12-31

Brief Summary

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The purpose of this study is to compare refractive outcomes after two different types of combined cataract surgery, namely microinscision cataract surgery and smallincision cataract surgery, and sutureless 23-gauge vitrectomy in patients presenting with vitreoretinal disorders and coexisting cataracts.

Detailed Description

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Purpose:

To compare refractive outcomes after combined cataract and vitreoretinal surgery.

Methods:

Patients with a diagnosis of vitreoretinal disorder and a coexisting significant cataract were randomly assigned to be treated with a microincision cataract surgery and a 23-gauge vitrectomy (treatment group 1) or with a smallincision cataract surgery and a 23-gauge vitrectomy (treatment group 2).

Main outcome measures:

Refractive outcomes, stability of the intraocular lens (IOL), intraocular pressure (IOP) and functional outcomes.

Conditions

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Cataract Extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Micro

Microincision cataract surgery

Group Type ACTIVE_COMPARATOR

Combined Micro- Surgery

Intervention Type PROCEDURE

Microincision Cataract Surgery combined with 23-gauge/25-gauge/27 gauge Vitrectomy

Small

Smallincision cataract surgery

Group Type ACTIVE_COMPARATOR

Combined Small-Surgery

Intervention Type PROCEDURE

Smallincision cataract surgery combined with 23 gauge vitrectomy

Interventions

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Combined Micro- Surgery

Microincision Cataract Surgery combined with 23-gauge/25-gauge/27 gauge Vitrectomy

Intervention Type PROCEDURE

Combined Small-Surgery

Smallincision cataract surgery combined with 23 gauge vitrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* diagnosis vitreoretinal disorder with coexisting cataract
* combined surgery
* age over 60 years
* IOL master for preoperative intraocularlens (IOL) calculation

Exclusion Criteria

* ultrasound for IOL calculation due to hazy media (dense cataract,vitreous hemorrhage)
* macular edema, proliferative diabetic retinopathy
* myopia or hyperopia more than 5 diopters, astigmatism more than 2 diopters
* previous refractive surgery, retinal detachment surgery, glaucoma surgery and vitrectomy
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

OTHER

Sponsor Role lead

Responsible Party

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Dr. Christiane I. Falkner-Radler

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susanne Binder, Univ.Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Ludwig Boltzmann Institute of Retinology and biomicroscopic Lasersurgery

Christiane I Falkner-Radler, M.D.

Role: STUDY_CHAIR

Ludwig Boltzmann Institut of Retinology and biomicroscopic Lasersurgery

Locations

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Rudolf Foundation Clinic

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Christiane I Falkner-Radler, MD

Role: CONTACT

+43-1-71165-4607

Katharina Krepler, Priv.Doz.Dr.

Role: CONTACT

Facility Contacts

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Christiane I Falkner-Radler, M.D.

Role: primary

+43-1-71165-4607

Other Identifiers

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FR-6-CI-2010

Identifier Type: -

Identifier Source: org_study_id

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