Clinical trial NCT02138123: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Pseudoaphakia
Keywords: dense cataract
phacoemulsification
lens-shell technique
intraocular lens
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2014-05-14
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Central corneal endothelial cell loss
timeFrame: one month
Secondary outcomes:
measure: central cornea thickness
timeFrame: one month
Other outcomes:
measure: un-corrected visual acuity
timeFrame: one month
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center,Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, Ph.D.
role: STUDY_CHAIR
References:
citation: Shah PA, Yoo S. Innovations in phacoemulsification technology. Curr Opin Ophthalmol. 2007 Feb;18(1):23-6. doi: 10.1097/ICU.0b013e328011f9d0.
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.
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.
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.