CataractsNCT01250964
Endothelial Cell Loss and Induced Astigmatism After Wound-directed and Wound-assisted IOL Injection
A study testing Lens insertion during cataract surgery in people with Cataracts and Cataract Surgery, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataracts, Cataract Surgery
- What is being tested?
- Lens insertion during cataract surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients include those who undergo uncomplicated cataract extraction surgery and IOL implantation by KLC.
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kittner Eye Center
Chapel Hill, North Carolina, 27599
About this study
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
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.
Read the 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
- Conditions
- Cataracts, Cataract Surgery
- Being tested
- Lens insertion during cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens insertion during cataract surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Wound-assisted lens injection | Active comparator | Wound-assisted lens injection is considered neither superior or inferior to wound-directed lens injection. Receives: Procedure: Lens insertion during cataract surgery |
| Wound-directed lens injection | Active comparator | Wound-directed lens injection is neither considered superior nor inferior to wound-assisted lens injection. Receives: Procedure: Lens insertion during cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgically induced astigmatism
measured by topography at 1 month post operative visit
Measured: 1 month
Secondary outcomes (3)
Endothelial cell loss
As measured by specular microscopy
Measured: one month
Best corrected visual acuity
By manifest refraction
Measured: one month
Final incision size
measured with incision gauges before and after lens injection.
Measured: intraoperatively (day #0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CataractsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth Cohen, MD, Principal investigator, UNC dept. of ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250964
- Sponsor's protocol ID
- 10-0435
- Status last verified
- Nov 2010
- First submitted
- 29 Nov 2010
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12842669Kamae 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.
PubMed 19631132Osher 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.
PubMed 17321390Kohnen 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.
PubMed 18812128Ventura 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.
PubMed 11133705Masket 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.
PubMed 19244949
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01250964
- Acronym / sponsor ID
- 10-0435
- Conditions
- Cataracts, Cataract Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wound-assisted lens injection | Active comparator | Procedure: Lens insertion during cataract surgeryWound-assisted lens injection is considered neither superior or inferior to wound-directed lens injection. |
| Wound-directed lens injection | Active comparator | Procedure: Lens insertion during cataract surgeryWound-directed lens injection is neither considered superior nor inferior to wound-assisted lens injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients include those who undergo uncomplicated cataract extraction surgery and IOL implantation by KLC.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lens insertion during cataract surgeryAfter 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. | Procedure or surgery | Wound-assisted lens injection, Wound-directed lens injection |
Primary outcome
Surgically induced astigmatism
Time frame: 1 month
measured by topography at 1 month post operative visit
3 secondary outcomes
Endothelial cell loss
Time frame: one month
Best corrected visual acuity
Time frame: one month
Final incision size
Time frame: intraoperatively (day #0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2010.
- Background: PubMed 12842669Tsuneoka 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.
- Background: PubMed 19631132Kamae 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.
- Background: PubMed 17321390Osher 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.
- Background: PubMed 18812128Kohnen 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.
- Background: PubMed 11133705Ventura 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.
- Background: PubMed 19244949Masket 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Cohen, MD principal investigator
UNC dept. of ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lens insertion during cataract surgery in people with Cataracts and Cataract Surgery, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgically induced astigmatism (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01250964, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2010.