Intraocular Lens-shell Technique in Phacoemulsification
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|ClinicalTrials.gov Identifier: NCT02138123|
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : June 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cataract Pseudoaphakia||Procedure: IOL-shell technique Procedure: Conventional procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Intraocular Lens-Shell Technique: An Adjustment of Surgical Procedure Makes Differences in Treating Dense Nucleus Cataract|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: IOL-shell technique
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.
Procedure: IOL-shell technique
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.
Active Comparator: Conventional procedure
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.
Procedure: Conventional procedure
In this procedure, a IOL was not implanted until all the nuclear fragments were removed.
- Central corneal endothelial cell loss [ Time Frame: one month ]Central corneal endothelial cell loss was calculated by subtracting postoperative corneal endothelial cell density from the preoperative baseline level.
- central cornea thickness [ Time Frame: one month ]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.
- un-corrected visual acuity [ Time Frame: one month ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138123
|Zhongshan Ophthalmic Center,Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510060|
|Study Chair:||Yizhi Liu, Ph.D.||Zhongshan Ophthalmic Center, Sun Yat-sen University|