Microincision Versus Smallincision Combined Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Sponsor:
Information provided by (Responsible Party):
Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT01198483
First received: September 7, 2010
Last updated: January 24, 2016
Last verified: January 2016

September 7, 2010
January 24, 2016
August 2011
December 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01198483 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Microincision Versus Smallincision Combined Surgery
Microincision Cataract Surgery Combined With 23-gauge Vitrectomy Versus Smallincision Cataract Surgery Combined With 23-gauge Vitrectomy
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cataract Extraction
  • Procedure: Combined Micro- Surgery
    Microincision Cataract Surgery combined with 23-gauge/25-gauge/27 gauge Vitrectomy
  • Procedure: Combined Small-Surgery
    Smallincision cataract surgery combined with 23 gauge vitrectomy
  • Active Comparator: Micro
    Microincision cataract surgery
    Intervention: Procedure: Combined Micro- Surgery
  • Active Comparator: Small
    Smallincision cataract surgery
    Intervention: Procedure: Combined Small-Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2017
December 2016   (final data collection date for primary outcome measure)

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
Both
60 Years and older   (Adult, Senior)
Yes
Contact: Christiane I Falkner-Radler, MD +43-1-71165-4607 christiane.falkner-radler@wienkav.at
Contact: Katharina Krepler, Priv.Doz.Dr.
Austria
 
NCT01198483
FR-6-CI-2010
No
Undecided
Not Provided
Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Not Provided
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
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
January 2016

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