Back to resultsIntraocular Lens-shell Technique in Phacoemulsification
Primary Purpose
Cataract, Pseudoaphakia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
IOL-shell technique
Conventional procedure
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring dense cataract, phacoemulsification, lens-shell technique, intraocular lens
Eligibility Criteria
Inclusion Criteria:
- Aged 50 years or above
- Dense cataract cases were defined as eyes in which the nuclear color was graded IV or V according to the Lens Opacities Classification System III (LOCS III). Special attention was paid in selecting cases without apparent posterior cortical layer.
- No central corneal opacification
- Pupil diameter >= 7 mm after full pharmacological dilation in preoperative assessment
- A preoperative central endothelial cell count of >= 1500 cells/mm2.
Exclusion Criteria:
- Participants with previous intraocular surgery
- Abnormal lens zonules
- Glaucoma
- High myopia (>-6.0 Diopters)
- Pseudoexfoliation
- Uveitis
- Diabetes mellitus
- Those who were not able to come for follow-up visits.
Sites / Locations
- Zhongshan Ophthalmic Center,Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IOL-shell technique
Conventional procedure
Arm Description
In this group, before the emulsification of the last nuclear fragment, cohesive viscoelastic material was injected below the nuclear fragment and a foldable IOL was implanted into the well inflated capsular bag posterior to the nuclear fragment. The remaining last piece of nuclear fragment was then emulsified and removed within the capsular bag.
In this group, a Sensar IOL (AMO Laboratories) was implanted in the capsular bag with the injector system after the lens material was completely removed. The nuclear fragmentation was performed using the Phaco-chop technique, which was then followed by ultrasound emulsification of the nuclear fragments piece by piece. Due to lack of cortical shell within the capsular bag, special care was taken to carry out the emulsification of the last nuclear fragment at a relatively more anterior anatomical position between the iris plan and the anterior chamber.
Outcomes
Primary Outcome Measures
Central corneal endothelial cell loss
Central corneal endothelial cell loss was calculated by subtracting postoperative corneal endothelial cell density from the preoperative baseline level.
Secondary Outcome Measures
central cornea thickness
The temporal corneal thickness and central corneal thickness were measured using the manual measurement scale in the scanning pictures of anterior segment optical coherence tomography preoperatively and at each postoperative visit.
Full Information
NCT ID
NCT02138123
First Posted
May 12, 2014
Last Updated
June 6, 2014
Sponsor
Sun Yat-sen University
Collaborators
National Natural Science Foundation of China
1. Study Identification
Unique Protocol Identification Number
NCT02138123
Brief Title
Intraocular Lens-shell Technique in Phacoemulsification
Official Title
Intraocular Lens-Shell Technique: An Adjustment of Surgical Procedure Makes Differences in Treating Dense Nucleus Cataract
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
National Natural Science Foundation of China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study, the investigators introduce a surgical procedure called "IOL-shell technique" in the purpose of reduce complications of surgeries for dense cataract, and report a prospective randomized controlled study aiming at assessing efficacy and safety of the IOL-shell technique, which showed that the new procedure offered a safer way for hard cataract surgery over the conventional phacoemulsification procedure without compromise in efficacy.
Detailed Description
A Prospective, randomized controlled study of 80 eyes with dense nucleus were enrolled. Patients were assigned to two groups: Group I: IOL was traditionally implanted after all nuclear fragments were completely removed, while in Group II, IOL was innovatively implanted in the bag before last residual nuclear fragment was removed. This novel adjusted surgical procedure, featured by using IOL as a protective barrier (named "IOL-shell technique"), not just as a refractive alternative, was conceptual different from the traditional step-by-step procedure. Clinical examinations including uncorrected visual acuity, central corneal thickness (CCT), temporal clear corneal thickness and the corneal endothelial cell density were carried out.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Pseudoaphakia
Keywords
dense cataract, phacoemulsification, lens-shell technique, intraocular lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IOL-shell technique
Arm Type
Experimental
Arm Description
In this group, before the emulsification of the last nuclear fragment, cohesive viscoelastic material was injected below the nuclear fragment and a foldable IOL was implanted into the well inflated capsular bag posterior to the nuclear fragment. The remaining last piece of nuclear fragment was then emulsified and removed within the capsular bag.
Arm Title
Conventional procedure
Arm Type
Active Comparator
Arm Description
In this group, a Sensar IOL (AMO Laboratories) was implanted in the capsular bag with the injector system after the lens material was completely removed. The nuclear fragmentation was performed using the Phaco-chop technique, which was then followed by ultrasound emulsification of the nuclear fragments piece by piece. Due to lack of cortical shell within the capsular bag, special care was taken to carry out the emulsification of the last nuclear fragment at a relatively more anterior anatomical position between the iris plan and the anterior chamber.
Intervention Type
Procedure
Intervention Name(s)
IOL-shell technique
Intervention Description
Phacoemulsification was performed with the same device and handpieces, using the same phaco chop technique as in the conventional procedure group. What was different was that before the emulsification of the last nuclear fragment, cohesive viscoelastic material was injected below the nuclear fragment and a foldable IOL was implanted into the well inflated capsular bag posterior to the nuclear fragment. The remaining last piece of nuclear fragment was then emulsified and removed within the capsular bag.
Intervention Type
Procedure
Intervention Name(s)
Conventional procedure
Intervention Description
In this procedure, a IOL was not implanted until all the nuclear fragments were removed.
Primary Outcome Measure Information:
Title
Central corneal endothelial cell loss
Description
Central corneal endothelial cell loss was calculated by subtracting postoperative corneal endothelial cell density from the preoperative baseline level.
Time Frame
one month
Secondary Outcome Measure Information:
Title
central cornea thickness
Description
The temporal corneal thickness and central corneal thickness were measured using the manual measurement scale in the scanning pictures of anterior segment optical coherence tomography preoperatively and at each postoperative visit.
Time Frame
one month
Other Pre-specified Outcome Measures:
Title
un-corrected visual acuity
Description
The un-corrected visual acuity was measured and recorded using an Early Treatment Diabetic Retinopathy Study chart both before operation and at the 1st, 7th and 30th day after operation.
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 50 years or above
Dense cataract cases were defined as eyes in which the nuclear color was graded IV or V according to the Lens Opacities Classification System III (LOCS III). Special attention was paid in selecting cases without apparent posterior cortical layer.
No central corneal opacification
Pupil diameter >= 7 mm after full pharmacological dilation in preoperative assessment
A preoperative central endothelial cell count of >= 1500 cells/mm2.
Exclusion Criteria:
Participants with previous intraocular surgery
Abnormal lens zonules
Glaucoma
High myopia (>-6.0 Diopters)
Pseudoexfoliation
Uveitis
Diabetes mellitus
Those who were not able to come for follow-up visits.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, Ph.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Ophthalmic Center,Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
17159443
Citation
Shah PA, Yoo S. Innovations in phacoemulsification technology. Curr Opin Ophthalmol. 2007 Feb;18(1):23-6. doi: 10.1097/ICU.0b013e328011f9d0.
Results Reference
background
PubMed Identifier
22310081
Citation
Luo L, Lin H, He M, Congdon N, Yang Y, Liu Y. Clinical evaluation of three incision size-dependent phacoemulsification systems. Am J Ophthalmol. 2012 May;153(5):831-839.e2. doi: 10.1016/j.ajo.2011.10.034. Epub 2012 Feb 4.
Results Reference
background
PubMed Identifier
20870105
Citation
Hwang HS, Kim EC, Kim MS. Drill-and-crack technique for nuclear disassembly of hard nucleus. J Cataract Refract Surg. 2010 Oct;36(10):1627-30. doi: 10.1016/j.jcrs.2010.08.003.
Results Reference
background
PubMed Identifier
25401512
Citation
Luo L, Lin H, Chen W, Qu B, Zhang X, Lin Z, Chen J, Liu Y. Intraocular lens-shell technique: adjustment of the surgical procedure leads to greater safety when treating dense nuclear cataracts. PLoS One. 2014 Nov 17;9(11):e112663. doi: 10.1371/journal.pone.0112663. eCollection 2014.
Results Reference
derived
Links:
URL
http://www.gzzoc.com/
Description
Homepage of Zhongshan Ophthalmic Center
Learn more about this trial
Intraocular Lens-shell Technique in Phacoemulsification
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