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Microincision Versus Smallincision Combined Surgery

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ClinicalTrials.gov Identifier: NCT01198483
Recruitment Status : Recruiting
First Posted : September 10, 2010
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

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.

Condition or disease Intervention/treatment Phase
Cataract Extraction Procedure: Combined Micro- Surgery Procedure: Combined Small-Surgery Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Microincision Cataract Surgery Combined With 23-gauge Vitrectomy Versus Smallincision Cataract Surgery Combined With 23-gauge Vitrectomy
Study Start Date : August 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Refractive outcome [ Time Frame: 12 weeks after surgery ]
    Refractive outcome includes autorefraction using Humphrey Automatic Refractor/Keratometer(Carl Zeiss AG, Oberkochen, Germany) and subjective manifest refraction.


Secondary Outcome Measures :
  1. measurements of anterior chamber depth (ACD) [ Time Frame: 12 weeks after surgery ]
    measurements of anterior chamber depth (ACD )to evalute the stability of the intraocular lens (IOL) using the Pentacam (OCULUS GmbH, Wetzlar, Germany)

  2. intraocular pressure (IOP) [ Time Frame: 12 weeks after surgery ]
    to evaluate the stability of the eye after sutureless 23-gauge vitrectomy

  3. functional outcome [ Time Frame: 12 weeks after surgery ]
    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)



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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. Christiane I. Falkner-Radler, 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