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Microincision Versus Smallincision Combined Surgery

T

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Status

Unknown

Conditions

Cataract Extraction

Treatments

Procedure: Combined Micro- Surgery
Procedure: Combined Small-Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01198483
FR-6-CI-2010

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Micro
Active Comparator group
Description:
Microincision cataract surgery
Treatment:
Procedure: Combined Micro- Surgery
Small
Active Comparator group
Description:
Smallincision cataract surgery
Treatment:
Procedure: Combined Small-Surgery

Trial contacts and locations

1

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Central trial contact

Katharina Krepler, Priv.Doz.Dr.; Christiane I Falkner-Radler, MD

Data sourced from clinicaltrials.gov

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