Endothelial Cell Loss and Induced Astigmatism After Wound-directed and Wound-assisted IOL Injection

Study Overview
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Brief Summary
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The purpose of this study is to determine if there is any difference in astigmatism (eye surface curvature) or corneal endothelial cell density (the inner cell lining of the eye surface) after two different methods for inserting a lens during cataract surgery.

Detailed Description
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Cataract surgery (removal of a cloudy lens) is currently performed through increasingly smaller incisions. Bimanual surgery, where two instruments are used to remove the lens, is performed through two 1.4 mm incisions. Typically, one of these incisions is enlarged to 2.2 or 2.4 mm in order that the IOL (artificial lens) can be inserted into the eye. Surgeons insert these lenses by placing a lens injector cartridge completely into the eye (wound-directed insertion) or by placing only the tip inside the incision (wound-assisted insertion). While wound-assisted insertion can be performed through slightly smaller incisions (2.2 mm versus 2.4 mm for wound-directed insertion), both methods of insertion cause some incision enlargement. There is some evidence that wound-assisted insertion can cause very short-term pressure within the eye to go up. Neither method is considered inferior or superior to the other, and the primary investigator (Dr. Kenneth Cohen) routinely uses both methods. No studies have directly compared wound-healing characteristics between these two methods. We seek to compare differences in: Surgically-induced astigmatism (changes in the corneal curvature from cataract surgery incisions. Endothelial cell density loss. Endothelial cells line the inside surface of the cornea, and their overall density can be decreased by cataract surgery. Best-corrected vision after surgery Sizes of the incisions after lens injection

Official Title
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Endothelial Cell Loss and Surgically Induced Astigmatism After 2.2 mm Wound Assisted vs 2.4 mm Wound-Directed Clear Corneal Incisions for Intraocular Lens Insertion During Cataract Surgery

Conditions
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Cataracts, Cataract Surgery

Intervention / Treatment
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* Procedure: Lens insertion during cataract surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible patients include those who undergo uncomplicated cataract extraction surgery and IOL implantation by KLC. Exclusion Criteria: Patients who: suffer from diabetes and have more than mild background diabetic retinopathy, have a history of intraocular surgery, have a history of ocular trauma, have known pathology of the cornea, have a history of intraocular inflammation, are unable to understand English, are decisionally impaired, are currently incarcerated, or are less than 18 years of age. No exclusions will be made on the basis of gender, ethnicity, or race.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wound-assisted lens injection<br>Wound-assisted lens injection is considered neither superior or inferior to wound-directed lens injection. | Procedure: Lens insertion during cataract surgery<br>* After cataract removal during cataract surgery, a lens needs to be injected into the eye. Both arms are routinely used but different methods for injecting the lens.<br>|
| Active Comparator: Wound-directed lens injection<br>Wound-directed lens injection is neither considered superior nor inferior to wound-assisted lens injection. | Procedure: Lens insertion during cataract surgery<br>* After cataract removal during cataract surgery, a lens needs to be injected into the eye. Both arms are routinely used but different methods for injecting the lens.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgically induced astigmatism | measured by topography at 1 month post operative visit | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell loss | As measured by specular microscopy | one month | 
| Best corrected visual acuity | By manifest refraction | one month | 
| Final incision size | measured with incision gauges before and after lens injection. | intraoperatively (day #0) |