Intraocular Lens-Shell Technique: An Adjustment of Surgical Procedure Makes Differences in Treating Dense Nucleus Cataract
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Central corneal endothelial cell loss
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •High myopia (>-6.0 Diopters)
- •Pseudoexfoliation
- •Diabetes mellitus
- •Those who were not able to come for follow-up visits.
Outcomes
Primary Outcomes
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
- central cornea thickness(one month)
Investigators
Haotian Lin
Ophthalmologist
Sun Yat-sen University