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

This study has been completed.
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01250964
First received: November 29, 2010
Last updated: November 30, 2010
Last verified: November 2010

November 29, 2010
November 30, 2010
April 2010
November 2010   (final data collection date for primary outcome measure)
Surgically induced astigmatism [ Time Frame: 1 month ] [ Designated as safety issue: No ]
measured by topography at 1 month post operative visit
Same as current
Complete list of historical versions of study NCT01250964 on ClinicalTrials.gov Archive Site
  • Endothelial cell loss [ Time Frame: one month ] [ Designated as safety issue: No ]
    As measured by specular microscopy
  • Best corrected visual acuity [ Time Frame: one month ] [ Designated as safety issue: No ]
    By manifest refraction
  • Final incision size [ Time Frame: intraoperatively (day #0) ] [ Designated as safety issue: No ]
    measured with incision gauges before and after lens injection.
Same as current
Not Provided
Not Provided
 
Endothelial Cell Loss and Induced Astigmatism After Wound-directed and Wound-assisted IOL Injection
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

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.

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:

  1. Surgically-induced astigmatism (changes in the corneal curvature from cataract surgery incisions.
  2. Endothelial cell density loss. Endothelial cells line the inside surface of the cornea, and their overall density can be decreased by cataract surgery.
  3. Best-corrected vision after surgery
  4. Sizes of the incisions after lens injection
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cataracts
  • Cataract Surgery
Procedure: Lens insertion during cataract surgery
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.
  • Active Comparator: Wound-assisted lens injection
    Wound-assisted lens injection is considered neither superior or inferior to wound-directed lens injection.
    Intervention: Procedure: Lens insertion during cataract surgery
  • Active Comparator: Wound-directed lens injection
    Wound-directed lens injection is neither considered superior nor inferior to wound-assisted lens injection.
    Intervention: Procedure: Lens insertion during cataract surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
November 2010
November 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01250964
10-0435
No
Dr. Kenneth Cohen, Dept. of Ophthalmology, UNC Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Kenneth Cohen, MD UNC dept. of ophthalmology
University of North Carolina, Chapel Hill
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP