Microincision Versus Smallincision Combined Surgery

Microincision Cataract Surgery Combined With 23-gauge Vitrectomy Versus Smallincision Cataract Surgery Combined With 23-gauge Vitrectomy

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01198483

Enrollment

Registered

2010-09-10

Start date

2011-08-31

Completion date

2018-12-31

Last updated

2016-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Extraction

Keywords

refraction, refractive error, combined surgery, microincision, smallincision, cataract surgery, vitrectomy

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.

Interventions

PROCEDURECombined Micro- Surgery

Microincision Cataract Surgery combined with 23-gauge/25-gauge/27 gauge Vitrectomy

PROCEDURECombined Small-Surgery

Smallincision cataract surgery combined with 23 gauge vitrectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
intraocular pressure (IOP)	12 weeks after surgery	to evaluate the stability of the eye after sutureless 23-gauge vitrectomy
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)

Countries

Austria

Contacts

Primary ContactChristiane I Falkner-Radler, MD

christiane.falkner-radler@wienkav.at+43-1-71165-4607

Backup ContactKatharina Krepler, Priv.Doz.Dr.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026