Microincision Versus Smallincision Combined Surgery

Cataract Extraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01198483
• Other study ID #: FR-6-CI-2010
• Status: Recruiting
• Phase: N/A
• First received: September 7, 2010
• Last updated: September 3, 2016
• Start date: August 2011
• Est. completion date: December 2018

Study information

• Verified date: September 2016
• Source: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
• Contact: Christiane I Falkner-Radler, MD
• Phone: +43-1-71165-4607
• Email: christiane.falkner-radler[@]wienkav.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Cataract Extraction

Intervention

Procedure:
• Combined Micro- Surgery
Microincision Cataract Surgery combined with 23-gauge/25-gauge/27 gauge Vitrectomy
• Combined Small-Surgery
Smallincision cataract surgery combined with 23 gauge vitrectomy

Locations

Country	Name	City	State
Austria	Rudolf Foundation Clinic	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refractive outcome	Refractive outcome includes autorefraction using Humphrey Automatic Refractor/Keratometer(Carl Zeiss AG, Oberkochen, Germany) and subjective manifest refraction.	12 weeks after surgery	No
Secondary	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)	12 weeks after surgery	No
Secondary	intraocular pressure (IOP)	to evaluate the stability of the eye after sutureless 23-gauge vitrectomy	12 weeks after surgery	No
Secondary	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)	12 weeks after surgery	No