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NCT Number: NCT02138123

Intraocular Lens-shell Technique in Phacoemulsification

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Pseudoaphakia

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center,Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Conventional procedure

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 14, 2014
Registry last updated
Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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