Clincosm LogoSign in Get a demo

Microincision Versus Smallincision Combined Surgery

Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery (Other)
Overall Status
Unknown status
CT.gov ID
NCT01198483
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
88
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Combined Micro- Surgery
  • Procedure: Combined Small-Surgery
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Aug 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Refractive outcome [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) [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) [12 weeks after surgery]

    to evaluate the stability of the eye after sutureless 23-gauge vitrectomy

  3. functional outcome [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Rudolf Foundation Clinic Vienna Austria 1030

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Christiane I. Falkner-Radler, MD, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT01198483
Other Study ID Numbers:
  • FR-6-CI-2010
First Posted:
Sep 10, 2010
Last Update Posted:
Sep 7, 2016
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Dr. Christiane I. Falkner-Radler, MD, 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

Study Results

No Results Posted as of Sep 7, 2016