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Intraocular Lens-shell Technique in Phacoemulsification

NCT02138123 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-06-09

No results posted yet for this study

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

Interventions

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.

PROCEDURE

Conventional procedure

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

Sponsors & Collaborators

  • National Natural Science Foundation of China

    collaborator OTHER_GOV

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yizhi Liu, Ph.D. · Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02138123 on ClinicalTrials.gov