Microincision Versus Smallincision Combined Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cataract Extraction

Intervention / Treatment
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* Procedure: Combined Micro- Surgery
* Procedure: Combined Small-Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Micro<br>Microincision cataract surgery | Procedure: Combined Micro- Surgery<br>* Microincision Cataract Surgery combined with 23-gauge/25-gauge/27 gauge Vitrectomy<br>|
| Active Comparator: Small<br>Smallincision cataract surgery | Procedure: Combined Small-Surgery<br>* Smallincision cataract surgery combined with 23 gauge vitrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive outcome | Refractive outcome includes autorefraction using Humphrey Automatic Refractor/Keratometer(Carl Zeiss AG, Oberkochen, Germany) and subjective manifest refraction. | 12 weeks after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refraction, refractive error, combined surgery, microincision, smallincision, cataract surgery, vitrectomy