Intraocular Lens-shell Technique in Phacoemulsification

NCT02138123 | Completed DMC

• 1 other identifier: CCPMOH2010-China5
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Pseudoaphakia

Keywords

dense cataract; phacoemulsification; lens-shell technique; intraocular lens

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• central cornea thickness

  one month

Other Outcomes (1)

• un-corrected visual acuity

  one month

Study Arms (2)

IOL-shell technique

EXPERIMENTAL

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

Conventional procedure

ACTIVE COMPARATOR

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

Interventions

IOL-shell technique PROCEDURE

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.

IOL-shell technique

Conventional procedure PROCEDURE

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

Conventional procedure

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Zhongshan Ophthalmic Center,Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (4)

• Shah PA, Yoo S. Innovations in phacoemulsification technology. Curr Opin Ophthalmol. 2007 Feb;18(1):23-6. doi: 10.1097/ICU.0b013e328011f9d0.

  PMID: 17159443 BACKGROUND

• 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.

  PMID: 22310081 BACKGROUND

• 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.

  PMID: 20870105 BACKGROUND

• 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.

  PMID: 25401512 DERIVED

Related Links

• Homepage of Zhongshan Ophthalmic Center

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Yizhi Liu, Ph.D.

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 14, 2014
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 9, 2014

Record last verified: 2014-06

Locations

CN (1)