Microincision Versus Smallincision Combined Surgery

This study is currently recruiting participants.

Verified September 2010 by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Sponsor:

Information provided by:

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

ClinicalTrials.gov Identifier:

NCT01198483

First received: September 7, 2010

Last updated: August 8, 2011

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2010

Last Updated Date

August 8, 2011

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Refractive outcome [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]

Refractive outcome includes autorefraction using Humphrey Automatic Refractor/Keratometer(Carl Zeiss AG, Oberkochen, Germany) and subjective manifest refraction.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01198483 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

measurements of anterior chamber depth (ACD) [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
measurements of anterior chamber depth (ACD )to evalute the stability of the intraocular lens (IOL) using the Pentacam (OCULUS GmbH, Wetzlar, Germany)
intraocular pressure (IOP) [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
to evaluate the stability of the eye after sutureless 23-gauge vitrectomy
functional outcome [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
Functional outcome includes testing of best corrected distance and near visual acuity (Logarithm of the minimum angle of resolution (logMAR) charts and Radner Reading charts)and optical coherence tomography (OCT)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Microincision Versus Smallincision Combined Surgery

Official Title ^ICMJE

Microincision Cataract Surgery Combined With 23-gauge Vitrectomy Versus Smallincision Cataract Surgery Combined With 23-gauge Vitrectomy

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Cataract Extraction

Intervention ^ICMJE

Procedure: Combined Micro- Surgery
Microincision Cataract Surgery combined with 23-gauge Vitrectomy
Procedure: Combined Small-Surgery
Smallincision cataract surgery combined with 23 gauge vitrectomy

Study Arm (s)

Active Comparator: Micro
Microincision cataract surgery

Intervention: Procedure: Combined Micro- Surgery
Active Comparator: Small
Smallincision cataract surgery

Intervention: Procedure: Combined Small-Surgery

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Christiane I Falkner-Radler, MD	+43-1-71165-4607	christiane.falkner-radler@wienkav.at
Contact: Katharina Krepler, Priv.Doz.Dr.

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT01198483

Other Study ID Numbers ^ICMJE

FR-6-CI-2010

Has Data Monitoring Committee

Responsible Party

Susanne Binder, Univ. Prof. Dr., The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Study Sponsor ^ICMJE

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Susanne Binder, Univ.Prof.Dr.	Ludwig Boltzmann Institute of Retinology and biomicroscopic Lasersurgery
Study Chair:	Christiane I Falkner-Radler, M.D.	Ludwig Boltzmann Institut of Retinology and biomicroscopic Lasersurgery

Information Provided By

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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