Cataract
Conditions
Keywords
Cataract
Brief summary
To compare the health economic parameter and clinical outcome of Phacoemulsification with small incision cataract surgery (SICS)
Interventions
PROCEDUREPhacoemulsification cataract extraction surgery
Surgical removal of cataract using phacoemulsification followed by implantation of an AcrySof Intraocular Lens (Model SN60WF)
PROCEDURESmall incision cataract surgery
Surgical removal of cataract using small incision cataract surgery (SICS) followed by implantation of a Polymethyl methacrylate(PMMA) Intraocular Lens (Model MZ60BD).
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient has senile cataract and require unilateral cataract extraction followed by implantation of an AcrySof or PMMA (polymethylmethacrylate) posterior chamber intraocular lens (IOL); * Pupil dilation ≧7 mm after mydrisis; * Patient undergoing cataract surgery for the first eye; * VA prognosis ≧6/12
Exclusion criteria
* Patients with history of ocular pathology or diabetic retinopathy; * Patients with traumatic, subluxated and posterior polar cataract; * Patients had ocular surgery in the past 6 months; * Patients with significant intra-operative complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posterior Capsule Opacification Evaluation | 12 months after surgery | The number of subjects with Posterior Capsular Opacification (PCO) for 12 months post-surgery of the study eye. PCO may occur after cataract surgery and is caused by residual lens epithelial cells that remain in the capsular bag after surgery and undergo proliferation, migration, and fibrous metaplasia. PCO was evaluated via slit lamp. A lower PCO rate is better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Astigmatism | 3 months after surgery | Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phaco cataract extraction surgery utilizing Phacoemulsification | 55 |
| SICS Small incision cataract surgery (SICS) | 51 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 18 | 13 |
Baseline characteristics
| Characteristic | Phaco | SICS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 47 Participants | 40 Participants | 87 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 11 Participants | 19 Participants |
| Sex: Female, Male Female | 33 Participants | 31 Participants | 64 Participants |
| Sex: Female, Male Male | 22 Participants | 20 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 55 | 6 / 51 |
| serious Total, serious adverse events | 0 / 55 | 0 / 51 |
Outcome results
Primary
Posterior Capsule Opacification Evaluation
The number of subjects with Posterior Capsular Opacification (PCO) for 12 months post-surgery of the study eye. PCO may occur after cataract surgery and is caused by residual lens epithelial cells that remain in the capsular bag after surgery and undergo proliferation, migration, and fibrous metaplasia. PCO was evaluated via slit lamp. A lower PCO rate is better.
Time frame: 12 months after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phaco | Posterior Capsule Opacification Evaluation | 3 participants |
| SICS | Posterior Capsule Opacification Evaluation | 28 participants |
Secondary
Corneal Astigmatism
Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.
Time frame: 3 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phaco | Corneal Astigmatism | 1.05 Diopters | Standard Deviation 0.8 |
| SICS | Corneal Astigmatism | 1.95 Diopters | Standard Deviation 1.15 |