An interventional study of Lens insertion during cataract surgery in Cataracts and Cataract Surgery, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-12-01.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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:
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 72 is close to the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria: Patients who:
No exclusions will be made on the basis of gender, ethnicity, or race.
Wound-assisted lens injection is considered neither superior or inferior to wound-directed lens injection.
Procedure: Lens insertion during cataract surgery
Wound-directed lens injection is neither considered superior nor inferior to wound-assisted lens injection.
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.
Surgically induced astigmatism
measured by topography at 1 month post operative visit
Time frame: 1 month
Endothelial cell loss
As measured by specular microscopy
Time frame: one month
Best corrected visual acuity
By manifest refraction
Time frame: one month
Final incision size
measured with incision gauges before and after lens injection.
Time frame: intraoperatively (day #0)
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of North Carolina, Chapel Hill