Microincision Versus Smallincision Combined Surgery
Microincision Cataract Surgery Combined With 23-gauge Vitrectomy Versus Smallincision Cataract Surgery Combined With 23-gauge Vitrectomy
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2010
CompletedFirst Posted
Study publicly available on registry
September 10, 2010
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedSeptember 7, 2016
September 1, 2016
6.3 years
September 7, 2010
September 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Refractive outcome
Refractive outcome includes autorefraction using Humphrey Automatic Refractor/Keratometer(Carl Zeiss AG, Oberkochen, Germany) and subjective manifest refraction.
12 weeks after surgery
Secondary Outcomes (3)
measurements of anterior chamber depth (ACD)
12 weeks after surgery
intraocular pressure (IOP)
12 weeks after surgery
functional outcome
12 weeks after surgery
Study Arms (2)
Micro
ACTIVE COMPARATORMicroincision cataract surgery
Small
ACTIVE COMPARATORSmallincision cataract surgery
Interventions
Microincision Cataract Surgery combined with 23-gauge/25-gauge/27 gauge Vitrectomy
Smallincision cataract surgery combined with 23 gauge vitrectomy
Eligibility Criteria
You may qualify if:
- diagnosis vitreoretinal disorder with coexisting cataract
- combined surgery
- age over 60 years
- IOL master for preoperative intraocularlens (IOL) calculation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rudolf Foundation Clinic
Vienna, 1030, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Katharina Krepler, Priv.Doz.Dr.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 7, 2010
First Posted
September 10, 2010
Study Start
August 1, 2011
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
September 7, 2016
Record last verified: 2016-09