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Microincision Versus Smallincision Combined Surgery

Primary Purpose

Cataract Extraction

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Combined Micro- Surgery
Combined Small-Surgery
Sponsored by
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Extraction focused on measuring refraction, refractive error, combined surgery, microincision, smallincision, cataract surgery, vitrectomy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rudolf Foundation ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Micro

Small

Arm Description

Microincision cataract surgery

Smallincision cataract surgery

Outcomes

Primary Outcome Measures

Refractive outcome
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)
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)
to evaluate the stability of the eye after sutureless 23-gauge vitrectomy
functional outcome
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)

Full Information

First Posted
September 7, 2010
Last Updated
September 3, 2016
Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT01198483
Brief Title
Microincision Versus Smallincision Combined Surgery
Official Title
Microincision Cataract Surgery Combined With 23-gauge Vitrectomy Versus Smallincision Cataract Surgery Combined With 23-gauge Vitrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Extraction
Keywords
refraction, refractive error, combined surgery, microincision, smallincision, cataract surgery, vitrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Micro
Arm Type
Active Comparator
Arm Description
Microincision cataract surgery
Arm Title
Small
Arm Type
Active Comparator
Arm Description
Smallincision cataract surgery
Intervention Type
Procedure
Intervention Name(s)
Combined Micro- Surgery
Intervention Description
Microincision Cataract Surgery combined with 23-gauge/25-gauge/27 gauge Vitrectomy
Intervention Type
Procedure
Intervention Name(s)
Combined Small-Surgery
Intervention Description
Smallincision cataract surgery combined with 23 gauge vitrectomy
Primary Outcome Measure Information:
Title
Refractive outcome
Description
Refractive outcome includes autorefraction using Humphrey Automatic Refractor/Keratometer(Carl Zeiss AG, Oberkochen, Germany) and subjective manifest refraction.
Time Frame
12 weeks after surgery
Secondary Outcome Measure Information:
Title
measurements of anterior chamber depth (ACD)
Description
measurements of anterior chamber depth (ACD )to evalute the stability of the intraocular lens (IOL) using the Pentacam (OCULUS GmbH, Wetzlar, Germany)
Time Frame
12 weeks after surgery
Title
intraocular pressure (IOP)
Description
to evaluate the stability of the eye after sutureless 23-gauge vitrectomy
Time Frame
12 weeks after surgery
Title
functional outcome
Description
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)
Time Frame
12 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christiane I Falkner-Radler, MD
Phone
+43-1-71165-4607
Email
christiane.falkner-radler@wienkav.at
First Name & Middle Initial & Last Name or Official Title & Degree
Katharina Krepler, Priv.Doz.Dr.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Binder, Univ.Prof.Dr.
Organizational Affiliation
Ludwig Boltzmann Institute of Retinology and biomicroscopic Lasersurgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christiane I Falkner-Radler, M.D.
Organizational Affiliation
Ludwig Boltzmann Institut of Retinology and biomicroscopic Lasersurgery
Official's Role
Study Chair
Facility Information:
Facility Name
Rudolf Foundation Clinic
City
Vienna
ZIP/Postal Code
1030
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christiane I Falkner-Radler, M.D.
Phone
+43-1-71165-4607
Email
christiane.falkner-radler@wienkav.at
First Name & Middle Initial & Last Name & Degree
Christiane I Falkner-Radler, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Microincision Versus Smallincision Combined Surgery

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