Aphakia, Cataract
Conditions
Keywords
Ocular Surgery, Intraocular Lens
Brief summary
The objective of this study is to test the hypothesis that the time to reach a stable refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision compared to eyes operated with the 2.75 mm standard incision using the Stellaris Vision Enhancement System.
Interventions
PROCEDURECoaxial Micro-Incision Cataract Surgery
1.8 mm coaxial micro incision
PROCEDURECoaxial Small Incision Cataract Surgery
2.75 mm coaxial incision
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must be undergoing bilateral primary in-the-bag intraocular lens (IOL) implantation for the correction of aphakia. * Subject's ocular media must be clear except for the presence of the cataract in both eyes.
Exclusion criteria
* Subject with any disease, which, in the Investigator's opinion, might interfere with the conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Refractive Stability | 12 weeks | Cumulative portion of eyes achieving refractive stability within 0.5 D of the final value for the remainder of the trial by surgical procedure and visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity | Visit 1, visit 2, visit 3, visit 4 | Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from preoperative visit summarized by visit. A minus change represents an improvement of the visual acuity |
| Uncorrected Visual Acuity | Visit 1, visit 2, visit 3, visit 4 | Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit. |
| Surgically Induced Astigmatism (SIA) | Visits 1-3 | Surgically induced astigmatism was presented in dioptres at each visit. |
Participant flow
Recruitment details
This study was conducted at one clinical site in Europe. First participant was enrolled on 8/25/2009 and last participant exited the study on 4/27/2010. Study lasted six months for enrollment and three months for follow-up.
Pre-assignment details
36 participants at least 50 years of age were enrolled in bilateral cataract surgery with phacoemulsification and intraocular lens implantation for the correction of aphakia. The Stellaris Vision Enhancement System was used for a 1.8mm Coaxial Micro-Incision procedure in one eye and a 2.75mm coaxial standard procedure in the contralateral eye.
Participants by arm
| Arm | Count |
|---|---|
| Cataract Surgery Cataract surgery with phacoemulsification using the Stellaris Vision Enhancement System | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Surgical complication | 1 |
Baseline characteristics
| Characteristic | Cataract Surgery |
|---|---|
| Age, Customized Aged 71 to 81 years | 36 participants |
| Region of Enrollment Europe | 36 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 33 / 36 | 33 / 35 | 66 / 71 |
| serious Total, serious adverse events | 1 / 36 | 0 / 35 | 5 / 36 |
Outcome results
Primary
Refractive Stability
Cumulative portion of eyes achieving refractive stability within 0.5 D of the final value for the remainder of the trial by surgical procedure and visit.
Time frame: 12 weeks
Population: Cumulative Proportion of Eyes Achieving Refractive Stability (within 0.5 D)- Full analysis Set (FAS) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Coaxial Micro-Incision Cataract Surgery | Refractive Stability | Visit 1 | 17 Eyes |
| Coaxial Micro-Incision Cataract Surgery | Refractive Stability | Visit 5 | 28 Eyes |
| Coaxial Micro-Incision Cataract Surgery | Refractive Stability | Visit 2 | 25 Eyes |
| Coaxial Micro-Incision Cataract Surgery | Refractive Stability | Visit 6 | 29 Eyes |
| Coaxial Micro-Incision Cataract Surgery | Refractive Stability | Visit 4 | 27 Eyes |
| Coaxial Micro-Incision Cataract Surgery | Refractive Stability | Visit 7 | 29 Eyes |
| Coaxial Micro-Incision Cataract Surgery | Refractive Stability | Visit 3 | 27 Eyes |
| Coaxial Small-Incision Cataract Surgery | Refractive Stability | Visit 7 | 33 Eyes |
| Coaxial Small-Incision Cataract Surgery | Refractive Stability | Visit 1 | 23 Eyes |
| Coaxial Small-Incision Cataract Surgery | Refractive Stability | Visit 2 | 25 Eyes |
| Coaxial Small-Incision Cataract Surgery | Refractive Stability | Visit 3 | 27 Eyes |
| Coaxial Small-Incision Cataract Surgery | Refractive Stability | Visit 4 | 28 Eyes |
| Coaxial Small-Incision Cataract Surgery | Refractive Stability | Visit 5 | 30 Eyes |
| Coaxial Small-Incision Cataract Surgery | Refractive Stability | Visit 6 | 31 Eyes |
Secondary
Best Corrected Visual Acuity
Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from preoperative visit summarized by visit. A minus change represents an improvement of the visual acuity
Time frame: Visit 1, visit 2, visit 3, visit 4
Population: Best Corrected Distance Visual Acuity (logMAR), Change from baseline, FAS Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coaxial Micro-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 2 | -0.37 logMAR | Standard Deviation 0.22 |
| Coaxial Micro-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 4 | -0.39 logMAR | Standard Deviation 0.24 |
| Coaxial Micro-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 3 | -0.38 logMAR | Standard Deviation 0.2 |
| Coaxial Micro-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 1 | -0.26 logMAR | Standard Deviation 0.24 |
| Coaxial Small-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 3 | -0.38 logMAR | Standard Deviation 0.27 |
| Coaxial Small-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 2 | -0.39 logMAR | Standard Deviation 0.26 |
| Coaxial Small-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 1 | -0.27 logMAR | Standard Deviation 0.29 |
| Coaxial Small-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 4 | -0.38 logMAR | Standard Deviation 0.27 |
Secondary
Best Corrected Visual Acuity
Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from baseline summarized by visit. A minus change represents an improvement of the visual acuity.
Time frame: visit 5, visit 6, visit 7, visit 8
Population: Best Corrected Distance Visual Acuity (logMAR), change from baseline, FAS Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coaxial Micro-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 5 | -0.40 logMAR | Standard Deviation 0.22 |
| Coaxial Micro-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 6 | -0.39 logMAR | Standard Deviation 0.24 |
| Coaxial Micro-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 7 | -0.40 logMAR | Standard Deviation 0.24 |
| Coaxial Micro-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 8 | -0.41 logMAR | Standard Deviation 0.22 |
| Coaxial Small-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 8 | -0.41 logMAR | Standard Deviation 0.28 |
| Coaxial Small-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 5 | -0.40 logMAR | Standard Deviation 0.27 |
| Coaxial Small-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 7 | -0.42 logMAR | Standard Deviation 0.26 |
| Coaxial Small-Incision Cataract Surgery | Best Corrected Visual Acuity | Visit 6 | -0.42 logMAR | Standard Deviation 0.27 |
Secondary
Surgically Induced Astigmatism (SIA)
Surgically induced astigmatism was presented in dioptres at each visit.
Time frame: Visits 1-3
Population: Surgically Induced Astigmatism, FAS Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coaxial Micro-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 1 | 0.70 Dioptres | Standard Deviation 0.55 |
| Coaxial Micro-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 2 | 0.45 Dioptres | Standard Deviation 0.39 |
| Coaxial Micro-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 3 | 0.41 Dioptres | Standard Deviation 0.21 |
| Coaxial Small-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 3 | 0.60 Dioptres | Standard Deviation 0.31 |
| Coaxial Small-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 1 | 0.80 Dioptres | Standard Deviation 0.49 |
| Coaxial Small-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 2 | 0.61 Dioptres | Standard Deviation 0.33 |
Secondary
Surgically Induced Astigmatism (SIA)
Surgically induced astigmatism presented in dioptres at each visit.
Time frame: Visits 4-8
Population: Surgically Induced Astigmatism-FAS Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coaxial Micro-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 5 | 0.39 Dioptres | Standard Deviation 0.36 |
| Coaxial Micro-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 7 | 0.37 Dioptres | Standard Deviation 0.31 |
| Coaxial Micro-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 6 | 0.37 Dioptres | Standard Deviation 0.27 |
| Coaxial Micro-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 8 | 0.37 Dioptres | Standard Deviation 0.21 |
| Coaxial Micro-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 4 | 0.44 Dioptres | Standard Deviation 0.37 |
| Coaxial Small-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 8 | 0.42 Dioptres | Standard Deviation 0.26 |
| Coaxial Small-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 4 | 0.52 Dioptres | Standard Deviation 0.31 |
| Coaxial Small-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 5 | 0.53 Dioptres | Standard Deviation 0.35 |
| Coaxial Small-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 6 | 0.59 Dioptres | Standard Deviation 0.3 |
| Coaxial Small-Incision Cataract Surgery | Surgically Induced Astigmatism (SIA) | Visit 7 | 0.51 Dioptres | Standard Deviation 0.31 |
Secondary
Uncorrected Visual Acuity
Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
Time frame: visit 5, visit 6, visit 7, visit 8
Population: Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coaxial Micro-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 5 | -0.36 logMAR | Standard Deviation 0.33 |
| Coaxial Micro-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 6 | -0.35 logMAR | Standard Deviation 0.31 |
| Coaxial Micro-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 7 | -0.36 logMAR | Standard Deviation 0.35 |
| Coaxial Micro-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 8 | -0.38 logMAR | Standard Deviation 0.31 |
| Coaxial Small-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 8 | -0.51 logMAR | Standard Deviation 0.32 |
| Coaxial Small-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 5 | -0.48 logMAR | Standard Deviation 0.32 |
| Coaxial Small-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 7 | -0.49 logMAR | Standard Deviation 0.33 |
| Coaxial Small-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 6 | -0.47 logMAR | Standard Deviation 0.34 |
Secondary
Uncorrected Visual Acuity
Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
Time frame: Visit 1, visit 2, visit 3, visit 4
Population: Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coaxial Micro-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 1 | -0.22 logMAR | Standard Deviation 0.32 |
| Coaxial Micro-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 2 | -0.37 logMAR | Standard Deviation 0.29 |
| Coaxial Micro-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 3 | -0.37 logMAR | Standard Deviation 0.3 |
| Coaxial Micro-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 4 | -0.36 logMAR | Standard Deviation 0.3 |
| Coaxial Small-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 4 | -0.46 logMAR | Standard Deviation 0.31 |
| Coaxial Small-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 1 | -0.34 logMAR | Standard Deviation 0.31 |
| Coaxial Small-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 3 | -0.41 logMAR | Standard Deviation 0.32 |
| Coaxial Small-Incision Cataract Surgery | Uncorrected Visual Acuity | Visit 2 | -0.45 logMAR | Standard Deviation 0.31 |