Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wound-assisted lens injection | Active Comparator | Wound-assisted lens injection is considered neither superior or inferior to wound-directed lens injection. |
|
| Wound-directed lens injection | Active Comparator | Wound-directed lens injection is neither considered superior nor inferior to wound-assisted lens injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgically induced astigmatism | measured by topography at 1 month post operative visit | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial cell loss | As measured by specular microscopy | one month |
| Best corrected visual acuity | By manifest refraction | one month |
Not provided
Inclusion Criteria:
Exclusion Criteria: Patients who:
No exclusions will be made on the basis of gender, ethnicity, or race.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenneth Cohen, MD | UNC dept. of ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kittner Eye Center | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12842669 | Background | 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. | |
| 19631132 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Final incision size | measured with incision gauges before and after lens injection. | intraoperatively (day #0) |
| 17321390 | Background | 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. |
| 18812128 | Background | 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. |
| 11133705 | Background | 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. |
| 19244949 | Background | 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. |