Intraocular Lens-shell Technique in Phacoemulsification

Cataract Clinical Trial

Official title:

Intraocular Lens-Shell Technique: An Adjustment of Surgical Procedure Makes Differences in Treating Dense Nucleus Cataract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138123
• Other study ID #: CCPMOH2010-China5
• Status: Completed
• Phase: N/A
• First received: May 12, 2014
• Last updated: June 6, 2014
• Start date: December 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2014
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science FoundationChina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Pseudoaphakia

Intervention

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.
• Conventional procedure
In this procedure, a IOL was not implanted until all the nuclear fragments were removed.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center,Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View Citation

Shah PA, Yoo S. Innovations in phacoemulsification technology. Curr Opin Ophthalmol. 2007 Feb;18(1):23-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	un-corrected visual acuity	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.	one month	No
Primary	Central corneal endothelial cell loss	Central corneal endothelial cell loss was calculated by subtracting postoperative corneal endothelial cell density from the preoperative baseline level.	one month	No
Secondary	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.	one month	No

External Links

•   Homepage of Zhongshan Ophthalmic Center