Cataract
Conditions
Keywords
cataract, aspherical intraocular lenses, functional vision
Brief summary
This study is to compare intraindividually the functional vision provided by two different posterior chamber intraocular lenses: AMO Tecnis Z9000 and Alcon SA60AT Acrysoft. To see if the aspherical intraocular lenses provide better functional vision than traditional spherical intraocular lenses.
Detailed description
In this prospective study, 20 patients with bilateral catarct presenting for cataract surgery are randomly assigned to recieve an aspherical intraocular lens(AMO Tecnis Z9000) in one eye and a spherical intraocular lens(Alcon SA60AT Acrysof)in the other. All surgeries are performed by one experienced surgeon(Fung-Rong Hu,MD)with clear cornea small incision phacoemulsification and in-the-bag posterior chamber intraocular implantation. The patients are followed for 3 months, and postoperative contrast sensitivity, contrast acuity, corneal & total ocular high-ordered aberrations are measured and compared intraidividually between two different IOL groups. Outcome Measurement: 1. Contrast sensitivity testing: measured with spectacle correction for the target distance of three meters using wall-mounted FACT sine-wave grating chart with nine levels of contrast.The graphic contrast sensitivity is recorded as a log functional units on the y-axis and displayed for five spatial frequency targets (1.5, 3, 6, 12, 18 cycles per degree (cpd))on x- axis. 2. Contrast acuity testing: measured with spectacle correction for the target distance of three meters using logMAR letter chart(Precision Vision®)represented on a wall-mounted illuminator cabinet.Two types of contrast charts are used, high contrast(Cat.No.2103 SLOAN translucent chart)and low contrast(Cat.No.2132 10% SLOAN translucent chart),and are tested under both photopic and mesopic conditions. 3. Pupil diameters: measured by Colvard infrared pupillometer (Oasis. Medical, Glendora, CA, USA )under both photopic and mesopic luminance levels. 4. Corneal aberration analysis: performed with TMS-4 (Tomey, Japan).The corneal HOAs are described with Zernike polynomials of 3rd-to 5th- order root-mean-square(RMS)of central 6mm diameter using VOLPro 6.89 software(Fa. Sarver and Associates, Carbondale. Ill, USA). 5. Total ocular aberration analysis: performed with a Hartmann-Shack aberrometer(Zywave, Bausch & Lomb Inc., Rochester, New. York)under maximal mydriasis with Mydrin-P(phenylephrine hydrochloride 0.5% and tropicamide 0.5%, Santen).The wavefront errors were described using Zernike polynomials RMS for total HOA at pupil diameter of 5 mm and 6 mm, primary spherical (Z 4,0) and 3rd-to 5th-order aberration at pupil diameter of 6 mm. Data Analysis: * Mann-Whitney U matched-paired test was used with STATA software * P values of 0.05 or less were considered statistically significant
Interventions
DEVICEaspherical intraocular lens
implantation of aspherical intraocular lenses(AMO Tecnis Z9000)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)
DEVICEspherical intraocular lens
implantation of spherical intraocular lenses(Alcon SA60AT Acrysof)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)
Sponsors
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Bilateral cataracts, eligible for phacoemulsification with primary implantation of a posterior chamber IOL * Willing and able to comply with scheduled visits and other study procedures
Exclusion criteria
* Preoperative ocular pathology potentially affect visual acuity. EX: diabetic retinopathy, macular degeneration, corneal opacity, glaucoma, visual field defect...etc. * Previous ocular surgery. Ex: refractive surgery, vitreoretinal surgery...etc. * Patients who cannot cooperative with the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition | average data of post-op 3rd, 6th, 12th week measurements | Contrast acuity testing was measured with spectacle correction for the target distance of three meters using a logMAR letter chart (Precision Vision®) represented on a wall-mounted illuminator cabinet. Two types of contrast charts were used, high contrast (Cat.No.2103 SLOAN translucent chart) and low contrast (Cat.No.2132 10% SLOAN translucent chart), and these were tested under both photopic (250 Lux) and mesopic (0.5 Lux) conditions. The contrast acuity tested ranges from 20/160 to 20/20(from worse to best), which equals LogMAR(Logarithm of the Minimum Angle of Resolution)0.9 to -0.3. All of the visual acuity and functional vision testing examinations mentioned above were performed by a single ophthalmologist. The outcomes were recorded as average of three post-operative measurments. |
| Best Corrected Contrast Sensitivity in Photopic Condition | average data of post-operative 3rd week, 6th week, 12th week measurements | Contrast sensitivity testing was measured with spectacle correction for the target distance of three meters using a wall-mounted FACT sine-wave grating chart with nine levels of contrast (Stereo Optical Inc.)and five spatial frequency targets (1.5, 3, 6, 12, 18 cycles per degree (cpd)) at 250 lux. The last correct grating seen for each spatial frequency is recorded and translated by the EYEVIEW™ Functional Analysis Software into a log contrast sensitivity unit. The outcomes were recorded as average of the three post-operative measurements. ( physiological range of contrast sensitivity: 1.5 cpd : 25\ 82.5 ; 3 cpd: 30\ 150 ; 6 cpd: 65 \ 200 ; 12 cpd: 20 \ 130 ; 18 cpd: 6.5 \ 65 ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal High-order Aberrations | pre-op & averate data of post-op 3rd, 6th, 12th week measurements | Corneal topography was performed with a TMS-4 corneal tomographer (Tomey, Japan). We used the 31-rings placido-based system that covers 10.9 mm of corneal diameter which is sufficient for the study of aberrations up to the fifth order for 6 mm diameter. Corneal HOAs were described with Zernike polynomials of 3rd- to 5th-order root-mean-square (RMS) of central 6mm diameter using VOLPro 6.89 software (Fa. Sarver and Associates, Carbondale. Ill, USA). |
| Total Ocular High-order Aberrations | average data of post-op 3rd, 6th, 12th week measurements | A Hartmann-Shack aberrometer (Zywave, Bausch & Lomb Inc., Rochester, New York ) was used for measurement of HOAs of the whole eye. The measurements were done under maximal mydriasis with Mydrin-P (phenylephrine hydrochloride 0.5% and tropicamide 0.5%, Santen). The wavefront errors were described using the RMS of Zernike polynomials for total HOA at pupil diameters of 5 mm and 6 mm, primary spherical (Z 4,0) and 3rd-to 5th-order aberration at the pupil diameter of 6 mm. |
Countries
Taiwan
Participant flow
Recruitment details
Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye. All cases were enrolled from October 2005 to April 2006 and were followed up for at least three months at the department of ophthalmology.
Pre-assignment details
Patients with diabetes or other systemic disease, such as dysthyroid related orbitopathy or drug related optic neuropathy, that may potentially affect contrast sensitivity and visual quality were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Cataract Patients Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Cataract Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 70.4 years STANDARD_DEVIATION 9.34 |
| Region of Enrollment Taiwan | 20 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Best Corrected Contrast Sensitivity in Photopic Condition
Contrast sensitivity testing was measured with spectacle correction for the target distance of three meters using a wall-mounted FACT sine-wave grating chart with nine levels of contrast (Stereo Optical Inc.)and five spatial frequency targets (1.5, 3, 6, 12, 18 cycles per degree (cpd)) at 250 lux. The last correct grating seen for each spatial frequency is recorded and translated by the EYEVIEW™ Functional Analysis Software into a log contrast sensitivity unit. The outcomes were recorded as average of the three post-operative measurements. ( physiological range of contrast sensitivity: 1.5 cpd : 25\ 82.5 ; 3 cpd: 30\ 150 ; 6 cpd: 65 \ 200 ; 12 cpd: 20 \ 130 ; 18 cpd: 6.5 \ 65 )
Time frame: average data of post-operative 3rd week, 6th week, 12th week measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spherical Intraocular Lens | Best Corrected Contrast Sensitivity in Photopic Condition | 3 cpd | 82.64 units on a scale | Standard Deviation 14.78 |
| Spherical Intraocular Lens | Best Corrected Contrast Sensitivity in Photopic Condition | 12 cpd | 23.47 units on a scale | Standard Deviation 17.73 |
| Spherical Intraocular Lens | Best Corrected Contrast Sensitivity in Photopic Condition | 6 cpd | 69.31 units on a scale | Standard Deviation 34.02 |
| Spherical Intraocular Lens | Best Corrected Contrast Sensitivity in Photopic Condition | 18 cpd | 6.97 units on a scale | Standard Deviation 3.99 |
| Spherical Intraocular Lens | Best Corrected Contrast Sensitivity in Photopic Condition | 1.5 cpd | 47.03 units on a scale | Standard Deviation 13.48 |
| Aspherical Intraocular Lens | Best Corrected Contrast Sensitivity in Photopic Condition | 18 cpd | 6.34 units on a scale | Standard Deviation 4.51 |
| Aspherical Intraocular Lens | Best Corrected Contrast Sensitivity in Photopic Condition | 1.5 cpd | 55.90 units on a scale | Standard Deviation 20.76 |
| Aspherical Intraocular Lens | Best Corrected Contrast Sensitivity in Photopic Condition | 3 cpd | 85.09 units on a scale | Standard Deviation 21.76 |
| Aspherical Intraocular Lens | Best Corrected Contrast Sensitivity in Photopic Condition | 6 cpd | 72.41 units on a scale | Standard Deviation 31.45 |
| Aspherical Intraocular Lens | Best Corrected Contrast Sensitivity in Photopic Condition | 12 cpd | 27.45 units on a scale | Standard Deviation 22.68 |
Primary
Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition
Contrast acuity testing was measured with spectacle correction for the target distance of three meters using a logMAR letter chart (Precision Vision®) represented on a wall-mounted illuminator cabinet. Two types of contrast charts were used, high contrast (Cat.No.2103 SLOAN translucent chart) and low contrast (Cat.No.2132 10% SLOAN translucent chart), and these were tested under both photopic (250 Lux) and mesopic (0.5 Lux) conditions. The contrast acuity tested ranges from 20/160 to 20/20(from worse to best), which equals LogMAR(Logarithm of the Minimum Angle of Resolution)0.9 to -0.3. All of the visual acuity and functional vision testing examinations mentioned above were performed by a single ophthalmologist. The outcomes were recorded as average of three post-operative measurments.
Time frame: average data of post-op 3rd, 6th, 12th week measurements
Population: we obtained data and calculated the probable sample size needed from the following reference papers:~1. Ophthalmologe 2005 Jan;102(1):51-7.~2. Acta Ophthalmol Scand 2004;82(6):718-22.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spherical Intraocular Lens | Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition | 0.34 log MAR | Standard Deviation 0.1 |
| Aspherical Intraocular Lens | Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition | 0.34 log MAR | Standard Deviation 0.1 |
Secondary
Corneal High-order Aberrations
Corneal topography was performed with a TMS-4 corneal tomographer (Tomey, Japan). We used the 31-rings placido-based system that covers 10.9 mm of corneal diameter which is sufficient for the study of aberrations up to the fifth order for 6 mm diameter. Corneal HOAs were described with Zernike polynomials of 3rd- to 5th-order root-mean-square (RMS) of central 6mm diameter using VOLPro 6.89 software (Fa. Sarver and Associates, Carbondale. Ill, USA).
Time frame: pre-op & averate data of post-op 3rd, 6th, 12th week measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spherical Intraocular Lens | Corneal High-order Aberrations | 0.10 μm | Standard Deviation 0.04 |
| Aspherical Intraocular Lens | Corneal High-order Aberrations | 0.11 μm | Standard Deviation 0.04 |
Secondary
Total Ocular High-order Aberrations
A Hartmann-Shack aberrometer (Zywave, Bausch & Lomb Inc., Rochester, New York ) was used for measurement of HOAs of the whole eye. The measurements were done under maximal mydriasis with Mydrin-P (phenylephrine hydrochloride 0.5% and tropicamide 0.5%, Santen). The wavefront errors were described using the RMS of Zernike polynomials for total HOA at pupil diameters of 5 mm and 6 mm, primary spherical (Z 4,0) and 3rd-to 5th-order aberration at the pupil diameter of 6 mm.
Time frame: average data of post-op 3rd, 6th, 12th week measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spherical Intraocular Lens | Total Ocular High-order Aberrations | 0.6314 μm | Standard Deviation 0.1342 |
| Aspherical Intraocular Lens | Total Ocular High-order Aberrations | 0.0856 μm | Standard Deviation 0.107 |