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OpenTrials
Completed

NCT Number: NCT01250964

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kittner Eye Center

Chapel Hill, North Carolina, 27599, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lens insertion during cataract surgery

Procedure

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 outcomes

  1. Surgically induced astigmatism

    Time frame: 1 month

    measured by topography at 1 month post operative visit

Secondary outcomes

  1. Endothelial cell loss

    Time frame: one month

    As measured by specular microscopy

  2. Best corrected visual acuity

    Time frame: one month

    By manifest refraction

  3. Final incision size

    Time frame: intraoperatively (day #0)

    measured with incision gauges before and after lens injection.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 1, 2010
Registry last updated
Dec 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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