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

Primary Purpose

Cataracts, Cataract Surgery

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lens insertion during cataract surgery
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eligible patients include those who undergo uncomplicated cataract extraction surgery and IOL implantation by KLC.

Exclusion Criteria: Patients who:

  1. suffer from diabetes and have more than mild background diabetic retinopathy,
  2. have a history of intraocular surgery,
  3. have a history of ocular trauma,
  4. have known pathology of the cornea,
  5. have a history of intraocular inflammation,
  6. are unable to understand English,
  7. are decisionally impaired,
  8. are currently incarcerated, or
  9. are less than 18 years of age.

No exclusions will be made on the basis of gender, ethnicity, or race.

Sites / Locations

  • Kittner Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Wound-assisted lens injection

Wound-directed lens injection

Arm Description

Wound-assisted lens injection is considered neither superior or inferior to wound-directed lens injection.

Wound-directed lens injection is neither considered superior nor inferior to wound-assisted lens injection.

Outcomes

Primary Outcome Measures

Surgically induced astigmatism
measured by topography at 1 month post operative visit

Secondary Outcome Measures

Endothelial cell loss
As measured by specular microscopy
Best corrected visual acuity
By manifest refraction
Final incision size
measured with incision gauges before and after lens injection.

Full Information

First Posted
November 29, 2010
Last Updated
November 30, 2010
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT01250964
Brief Title
Endothelial Cell Loss and Induced Astigmatism After Wound-directed and Wound-assisted IOL Injection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts, Cataract Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wound-assisted lens injection
Arm Type
Active Comparator
Arm Description
Wound-assisted lens injection is considered neither superior or inferior to wound-directed lens injection.
Arm Title
Wound-directed lens injection
Arm Type
Active Comparator
Arm Description
Wound-directed lens injection is neither considered superior nor inferior to wound-assisted lens injection.
Intervention Type
Procedure
Intervention Name(s)
Lens insertion during cataract surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Surgically induced astigmatism
Description
measured by topography at 1 month post operative visit
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Endothelial cell loss
Description
As measured by specular microscopy
Time Frame
one month
Title
Best corrected visual acuity
Description
By manifest refraction
Time Frame
one month
Title
Final incision size
Description
measured with incision gauges before and after lens injection.
Time Frame
intraoperatively (day #0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Cohen, MD
Organizational Affiliation
UNC dept. of ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kittner Eye Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12842669
Citation
Tsuneoka H, Hayama A, Takahama M. Ultrasmall-incision bimanual phacoemulsification and AcrySof SA30AL implantation through a 2.2 mm incision. J Cataract Refract Surg. 2003 Jun;29(6):1070-6. doi: 10.1016/s0886-3350(03)00076-2.
Results Reference
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PubMed Identifier
19631132
Citation
Kamae KK, Werner L, Chang W, Johnson JT, Mamalis N. Intraocular pressure changes during injection of microincision and conventional intraocular lenses through incisions smaller than 3.0 mm. J Cataract Refract Surg. 2009 Aug;35(8):1430-6. doi: 10.1016/j.jcrs.2009.03.038.
Results Reference
background
PubMed Identifier
17321390
Citation
Osher RH. Microcoaxial phacoemulsification Part 2: clinical study. J Cataract Refract Surg. 2007 Mar;33(3):408-12. doi: 10.1016/j.jcrs.2006.10.055.
Results Reference
background
PubMed Identifier
18812128
Citation
Kohnen T, Klaproth OK. Incision sizes before and after implantation of SN60WF intraocular lenses using the Monarch injector system with C and D cartridges. J Cataract Refract Surg. 2008 Oct;34(10):1748-53. doi: 10.1016/j.jcrs.2008.06.031.
Results Reference
background
PubMed Identifier
11133705
Citation
Ventura AC, Walti R, Bohnke M. Corneal thickness and endothelial density before and after cataract surgery. Br J Ophthalmol. 2001 Jan;85(1):18-20. doi: 10.1136/bjo.85.1.18.
Results Reference
background
PubMed Identifier
19244949
Citation
Masket S, Wang L, Belani S. Induced astigmatism with 2.2- and 3.0-mm coaxial phacoemulsification incisions. J Refract Surg. 2009 Jan;25(1):21-4. doi: 10.3928/1081597X-20090101-04.
Results Reference
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Endothelial Cell Loss and Induced Astigmatism After Wound-directed and Wound-assisted IOL Injection

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