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
  Purpose
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.

Condition Intervention
Cataract Extraction
Procedure: Combined Micro- Surgery
Procedure: Combined Small-Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Microincision Cataract Surgery Combined With 23-gauge Vitrectomy Versus Smallincision Cataract Surgery Combined With 23-gauge Vitrectomy

Resource links provided by NLM:


Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 80
Study Start Date: August 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Micro
Microincision cataract surgery
Procedure: Combined Micro- Surgery
Microincision Cataract Surgery combined with 23-gauge/25-gauge/27 gauge Vitrectomy
Active Comparator: Small
Smallincision cataract surgery
Procedure: Combined Small-Surgery
Smallincision cataract surgery combined with 23 gauge vitrectomy

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.

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198483

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

Locations
Austria
Rudolf Foundation Clinic Recruiting
Vienna, Austria, 1030
Contact: Christiane I Falkner-Radler, M.D.    +43-1-71165-4607    christiane.falkner-radler@wienkav.at   
Sub-Investigator: Christiane I Falkner-Radler, M.D.         
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Investigators
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
  More Information

Responsible Party: Dr. Christiane I. Falkner-Radler, MD, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT01198483     History of Changes
Other Study ID Numbers: FR-6-CI-2010 
Study First Received: September 7, 2010
Last Updated: January 24, 2016
Health Authority: Austria: Ethikkommission
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
refraction
refractive error
combined surgery
microincision
smallincision
cataract surgery
vitrectomy

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 25, 2016