Lens Implantation, IntraocularNCT00863759
Wavefront Analysis and Contrast Sensitivity After Cataract Surgery With Akreos Advanced Optics Intraocular Lens Implantation
A study testing implantation of intraocular lens (IOL) in people with Lens Implantation, Intraocular, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Purpose: To determine whether implantation of an intraocular lens (IOL) with a modified anterior and posterior aspherical surface (Akreos AO, Bausch \& Lomb,Inc) results in reduced ocular aberrations (spherical aberration) and in improved contrast sensitivity after cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lens Implantation, Intraocular
- What is being tested?
- implantation of intraocular lens (IOL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with bilateral visually significant cataract with corneal astigmatism lower than 2.0D (diopters)
Who cannot join
- Ocular diseases, such as corneal opacities or irregularity, dry eye amblyopia, anisometropia, glaucoma, retinal abnormalities
- Surgical complications
- Intraocular lens (IOL) tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination)
- Incomplete follow-up.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
: Department of ophthalmology, Hospital das Clinicas, University of São Paulo
São Paulo, São Paulo, 05403.001
About this study
Official title: Wavefront Analysis and Contrast Sensitivity After Cataract Surgery With Akreos AO Intraocular Lens Implantation: Clinical Comparative Study
Purpose: To determine whether implantation of an intraocular lens (IOL) with a modified anterior and posterior aspherical surface (Akreos AO, Bausch \& Lomb,Inc) results in reduced ocular aberrations (spherical aberration) and in improved contrast sensitivity after cataract surgery.
Study hypothesis: the implantation of an intraocular lens (IOL) with a modified anterior and posterior aspherical surface (Akreos AO, Bausch \& Lomb,Inc) results in reduced ocular aberrations (spherical aberration) and improved contrast sensitivity after cataract surgery.
Read more
Setting: Department of ophthalmology, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil.
Overall Study design: This will be an intraindividual randomized double-blinded prospective study. Patients will be randomized to receive an aspheric IOL Akreos AO in one eye (25 eyes; Bausch \& Lomb, Inc), and an spheric IOL Akreos Fit (25 eyes; Bausch \& Lomb, Inc.) in the fellow eye. Ocular aberrations with a 5.0 mm and 6.0 mm pupil will be measured with a dynamic retinoscopy aberrometer after 1 and 3 months. Uncorrected and best-corrected visual acuity, out-focus performance and contrast sensitivity under mesopic and photopic conditions will be also measured. All patients will be followed for 3 months.
Read the detailed description
Patients with bilateral visually significant cataract with corneal astigmatism lower than 2.0D (diopters) will be eligible for inclusion in the study. Exclusion criteria will be any ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination), or incomplete follow-up.
Patients will be examined before surgery and at 1, 7, 30, 90 days after surgery.
- Conditions
- Lens Implantation, Intraocular
- Being tested
- implantation of intraocular lens (IOL)
- Keywords
- intra-ocular lenses, comparative study, Ocular aberrations, Contrast Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantation of intraocular lens (IOL)Procedure or surgery
Also called Implantation of aspheric Akreos AO intraocular lenses (IOL), Implantation of spheric Akreos Fit intraocular lenses (IOL)
implantation of intraocular lens during cataract surgery.
Arm 1: implantation of aspheric IOL Akreos AO in right eye and an spheric IOL Akreos Fit in left eye.
Arm 2: implantation of aspheric IOL Akreos AO in left eye and an spheric IOL Akreos Fit in right eye.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients will receive an aspheric intraocular lenses (IOL) Akreos AO in the right eye and an spheric IOL Akreos Fit in the left eye, during cataract surgery. Receives: Procedure: implantation of intraocular lens (IOL) |
| 2 | Active comparator | Patients will receive an spheric intraocular lens (IOL) Akreos Fit in the right eye and an aspheric IOL Akreos AO in the left eye, during cataract surgery. Receives: Procedure: implantation of intraocular lens (IOL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular aberrations with a 5.0 mm and 6.0 mm pupil measured with a dynamic retinoscopy aberrometer
Measured: At 30 and 90 days postoperatively
Secondary outcomes (1)
Days contrast sensitivity under photopic and mesopic conditions
Measured: at 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lens Implantation, IntraocularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Marcony R Santhiago, MD, Principal investigator, University of Sao Paulo (ophthalmology department of Hospital das Clinicas)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863759
- Sponsor's protocol ID
- 656/06
- Status last verified
- Mar 2009
- First submitted
- 17 Mar 2009
- Last updated
- 2 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Montes-Mico R, Ferrer-Blasco T, Cervino A. Analysis of the possible benefits of aspheric intraocular lenses: review of the literature. J Cataract Refract Surg. 2009 Jan;35(1):172-81. doi: 10.1016/j.jcrs.2008.09.017.
PubMed 19101441Tzelikis PF, Akaishi L, Trindade FC, Boteon JE. Spherical aberration and contrast sensitivity in eyes implanted with aspheric and spherical intraocular lenses: a comparative study. Am J Ophthalmol. 2008 May;145(5):827-33. doi: 10.1016/j.ajo.2007.12.023. Epub 2008 Mar 4.
PubMed 18291345Kasper T, Buhren J, Kohnen T. Intraindividual comparison of higher-order aberrations after implantation of aspherical and spherical intraocular lenses as a function of pupil diameter. J Cataract Refract Surg. 2006 Jan;32(1):78-84. doi: 10.1016/j.jcrs.2005.11.018.
PubMed 16516783Dietze HH, Cox MJ. Limitations of correcting spherical aberration with aspheric intraocular lenses. J Refract Surg. 2005 Sep-Oct;21(5):S541-6. doi: 10.3928/1081-597X-20050901-24.
PubMed 16209458
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wavefront Analysis and Contrast Sensitivity After Cataract Surgery With Akreos AO Intraocular Lens Implantation: Clinical Comparative Study
- ClinicalTrials.gov ID
- NCT00863759
- Acronym / sponsor ID
- 656/06
- Conditions
- Lens Implantation, Intraocular
- Keywords
- intra-ocular lenses, comparative study, Ocular aberrations, Contrast Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To determine whether implantation of an intraocular lens (IOL) with a modified anterior and posterior aspherical surface (Akreos AO, Bausch \& Lomb,Inc) results in reduced ocular aberrations (spherical aberration) and in improved contrast sensitivity after cataract surgery.
Study hypothesis: the implantation of an intraocular lens (IOL) with a modified anterior and posterior aspherical surface (Akreos AO, Bausch \& Lomb,Inc) results in reduced ocular aberrations (spherical aberration) and improved contrast sensitivity after cataract surgery.
Setting: Department of ophthalmology, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil.
Overall Study design: This will be an intraindividual randomized double-blinded prospective study. Patients will be randomized to receive an aspheric IOL Akreos AO in one eye (25 eyes; Bausch \& Lomb, Inc), and an spheric IOL Akreos Fit (25 eyes; Bausch \& Lomb, Inc.) in the fellow eye. Ocular aberrations with a 5.0 mm and 6.0 mm pupil will be measured with a dynamic retinoscopy aberrometer after 1 and 3 months. Uncorrected and best-corrected visual acuity, out-focus performance and contrast sensitivity under mesopic and photopic conditions will be also measured. All patients will be followed for 3 months.
Detailed description
Patients with bilateral visually significant cataract with corneal astigmatism lower than 2.0D (diopters) will be eligible for inclusion in the study. Exclusion criteria will be any ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination), or incomplete follow-up.
Patients will be examined before surgery and at 1, 7, 30, 90 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: implantation of intraocular lens (IOL)Patients will receive an aspheric intraocular lenses (IOL) Akreos AO in the right eye and an spheric IOL Akreos Fit in the left eye, during cataract surgery. |
| 2 | Active comparator | Procedure: implantation of intraocular lens (IOL)Patients will receive an spheric intraocular lens (IOL) Akreos Fit in the right eye and an aspheric IOL Akreos AO in the left eye, during cataract surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with bilateral visually significant cataract with corneal astigmatism lower than 2.0D (diopters)
Key exclusion criteria (4 listed)
- Ocular diseases, such as corneal opacities or irregularity, dry eye amblyopia, anisometropia, glaucoma, retinal abnormalities
- Surgical complications
- Intraocular lens (IOL) tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination)
- Incomplete follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implantation of intraocular lens (IOL)Also: Implantation of aspheric Akreos AO intraocular lenses (IOL), Implantation of spheric Akreos Fit intraocular lenses (IOL)implantation of intraocular lens during cataract surgery. Arm 1: implantation of aspheric IOL Akreos AO in right eye and an spheric IOL Akreos Fit in left eye. Arm 2: implantation of aspheric IOL Akreos AO in left eye and an spheric IOL Akreos Fit in right eye. | Procedure or surgery | 1, 2 |
Primary outcome
Ocular aberrations with a 5.0 mm and 6.0 mm pupil measured with a dynamic retinoscopy aberrometer
Time frame: At 30 and 90 days postoperatively
1 secondary outcome
Days contrast sensitivity under photopic and mesopic conditions
Time frame: at 90 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2010.
- Background: PubMed 19101441Montes-Mico R, Ferrer-Blasco T, Cervino A. Analysis of the possible benefits of aspheric intraocular lenses: review of the literature. J Cataract Refract Surg. 2009 Jan;35(1):172-81. doi: 10.1016/j.jcrs.2008.09.017.
- Background: PubMed 18291345Tzelikis PF, Akaishi L, Trindade FC, Boteon JE. Spherical aberration and contrast sensitivity in eyes implanted with aspheric and spherical intraocular lenses: a comparative study. Am J Ophthalmol. 2008 May;145(5):827-33. doi: 10.1016/j.ajo.2007.12.023. Epub 2008 Mar 4.
- Background: PubMed 16516783Kasper T, Buhren J, Kohnen T. Intraindividual comparison of higher-order aberrations after implantation of aspherical and spherical intraocular lenses as a function of pupil diameter. J Cataract Refract Surg. 2006 Jan;32(1):78-84. doi: 10.1016/j.jcrs.2005.11.018.
- Background: PubMed 16209458Dietze HH, Cox MJ. Limitations of correcting spherical aberration with aspheric intraocular lenses. J Refract Surg. 2005 Sep-Oct;21(5):S541-6. doi: 10.3928/1081-597X-20050901-24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcony R Santhiago, MD principal investigator
University of Sao Paulo (ophthalmology department of Hospital das Clinicas)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implantation of intraocular lens (IOL) in people with Lens Implantation, Intraocular, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular aberrations with a 5.0 mm and 6.0 mm pupil measured with a dynamic retinoscopy aberrometer (time frame: At 30 and 90 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00863759, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2010.