Cataract ExtractionNCT01198483
Microincision Versus Smallincision Combined Surgery
A study testing Combined Micro- Surgery and Combined Small-Surgery in people with Cataract Extraction, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract Extraction
- What is being tested?
- Combined Micro- Surgery and Combined Small-Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2011to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis vitreoretinal disorder with coexisting cataract
- combined surgery
- age over 60 years
- IOL master for preoperative intraocularlens (IOL) calculation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Katharina Krepler, Priv.Doz.Dr. contact
Austria1 site, 1 recruiting
- Recruiting
Rudolf Foundation Clinic
Vienna, 1030
Christiane I Falkner-Radler, M.D., +43-1-71165-4607, christiane.falkner-radler@wienkav.at
Christiane I Falkner-Radler, M.D.
About this study
Official title: Microincision Cataract Surgery Combined With 23-gauge Vitrectomy Versus Smallincision Cataract Surgery Combined With 23-gauge Vitrectomy
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.
Read the 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.
- Conditions
- Cataract Extraction
- Being tested
- Combined Micro- Surgery, Combined Small-Surgery
- Keywords
- refraction, refractive error, combined surgery, microincision, smallincision, cataract surgery, vitrectomy
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Micro- SurgeryProcedure or surgery
Microincision Cataract Surgery combined with 23-gauge/25-gauge/27 gauge Vitrectomy
Combined Small-SurgeryProcedure or surgery
Smallincision cataract surgery combined with 23 gauge vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| Micro | Active comparator | Microincision cataract surgery Receives: Procedure: Combined Micro- Surgery |
| Small | Active comparator | Smallincision cataract surgery Receives: Procedure: Combined Small-Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive outcome
Refractive outcome includes autorefraction using Humphrey Automatic Refractor/Keratometer(Carl Zeiss AG, Oberkochen, Germany) and subjective manifest refraction.
Measured: 12 weeks after surgery
Secondary outcomes (3)
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)
Measured: 12 weeks after surgery
intraocular pressure (IOP)
to evaluate the stability of the eye after sutureless 23-gauge vitrectomy
Measured: 12 weeks after surgery
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)
Measured: 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startAug 2011
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Investigators
- Susanne Binder, Univ.Prof.Dr., Principal investigator, Ludwig Boltzmann Institute of Retinology and biomicroscopic LasersurgeryChristiane I Falkner-Radler, M.D., Study chair, Ludwig Boltzmann Institut of Retinology and biomicroscopic Lasersurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198483
- Sponsor's protocol ID
- FR-6-CI-2010
- Status last verified
- Sep 2016
- First submitted
- 7 Sep 2010
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microincision Cataract Surgery Combined With 23-gauge Vitrectomy Versus Smallincision Cataract Surgery Combined With 23-gauge Vitrectomy
- ClinicalTrials.gov ID
- NCT01198483
- Acronym / sponsor ID
- FR-6-CI-2010
- Conditions
- Cataract Extraction
- Keywords
- refraction, refractive error, combined surgery, microincision, smallincision, cataract surgery, vitrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micro | Active comparator | Procedure: Combined Micro- SurgeryMicroincision cataract surgery |
| Small | Active comparator | Procedure: Combined Small-SurgerySmallincision cataract surgery |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis vitreoretinal disorder with coexisting cataract
- combined surgery
- age over 60 years
- IOL master for preoperative intraocularlens (IOL) calculation
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Micro- SurgeryMicroincision Cataract Surgery combined with 23-gauge/25-gauge/27 gauge Vitrectomy | Procedure or surgery | Micro |
| Combined Small-SurgerySmallincision cataract surgery combined with 23 gauge vitrectomy | Procedure or surgery | Small |
Primary outcome
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.
3 secondary outcomes
measurements of anterior chamber depth (ACD)
Time frame: 12 weeks after surgery
intraocular pressure (IOP)
Time frame: 12 weeks after surgery
functional outcome
Time frame: 12 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Cataract Extraction
RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Not yet recruitingObservational study
Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
Cataract
Active, not recruiting
Ocular Hypotony and Refractive Predictability in RRD Surgery
Rhegmatogenous Retinal Detachment, Hypotony Ocular
Not yet recruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharina Krepler, Priv.Doz.Dr. contact
Susanne Binder, Univ.Prof.Dr. principal investigator
Ludwig Boltzmann Institute of Retinology and biomicroscopic Lasersurgery
Christiane I Falkner-Radler, M.D. study chair
Ludwig Boltzmann Institut of Retinology and biomicroscopic Lasersurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Micro- Surgery and Combined Small-Surgery in people with Cataract Extraction, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christiane I Falkner-Radler, MD (+43-1-71165-4607, christiane.falkner-radler@wienkav.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refractive outcome (time frame: 12 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.