Microincision Versus Smallincision Combined Surgery

Not Applicable

• Conditions: Cataract Extraction
• Interventions: Procedure: Combined Micro- Surgery; Procedure: Combined Small-Surgery

• Registration Number: NCT01198483
• Lead Sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

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.

Study Timeline

• Study First Submitted: 2010-09-07
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-10
• Study Start: 2011-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-03
• Last Update Posted: 2016-09-07
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Micro	Combined Micro- Surgery	Microincision cataract surgery
Small	Combined Small-Surgery	Smallincision cataract surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Rudolf Foundation Clinic; 🇦🇹 Vienna, Austria