Microincision Versus Smallincision Combined Surgery
This study is currently recruiting participants.
Verified September 2010 by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Sponsor:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT01198483
First received: September 7, 2010
Last updated: August 8, 2011
Last verified: September 2010
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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: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (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 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 |
| 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
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
No publications provided
| Responsible Party: | Susanne Binder, Univ. Prof. Dr., 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: | August 8, 2011 |
| Health Authority: | Austria: Ethikkommission |
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 June 17, 2013