Intraocular Lens-shell Technique in Phacoemulsification
- Conditions
- CataractPseudoaphakia
- Interventions
- Procedure: IOL-shell techniqueProcedure: Conventional procedure
- Registration Number
- NCT02138123
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IOL-shell technique IOL-shell technique 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. Conventional procedure Conventional procedure 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.
- Primary Outcome Measures
Name Time Method Central corneal endothelial cell loss one month Central corneal endothelial cell loss was calculated by subtracting postoperative corneal endothelial cell density from the preoperative baseline level.
- Secondary Outcome Measures
Name Time Method central cornea thickness 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.
Trial Locations
- Locations (1)
Zhongshan Ophthalmic Center,Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China