CataractNCT03726606
A Comparison of the Visual Performance of Trifocal Versus Extended Depth of Focus Intraocular Lenses
A study testing Intraocular lens in people with Cataract and Lenses, run by Hashmanis Hospital.
Trial summary
We are conducting a trial evaluating the performance of trifocal versus extended depth of focus intraocular lenses. These lenses will be implanted in otherwise healthy individuals with visual problems due to bilateral cataracts. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Cataract, Lenses, Visual Impairment
- What is being tested?
- Intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2018to 6 May 2019
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 30 years of age or older
- Has bilateral cataracts with visual problems
- Is motivated for vision correction
Who cannot join
- Any ocular pathology that could impair vision, for example:
- Pseudoexfoliation syndrome
- Zonular weakness
- Retinal or corneal dystrophies
- Retinal pathologies like age related macular degeneration
- History of trauma
Show all 12Show fewer
- History of ocular surgery
- Individuals having trouble understanding written or spoken language
- Those with dense cataracts causing problems with optical biometry
- Average corneal powers outside the range of 41 diopters (D) to 46 D
- Corneal astigmatism > 0.75 D
- Irregular astigmatism index of 0.54 or higher
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Controlled, Two-armed, and Single Blind Trial Evaluating the Visual Performance and Quality of Vision After Bilateral Implantation of 2 Presbyopia Correcting Intraocular Lenses: Trifocal Versus Extended Depth of Focus
We are conducting a trial evaluating the performance of trifocal versus extended depth of focus intraocular lenses. These lenses will be implanted in otherwise healthy individuals with visual problems due to bilateral cataracts. Patients must be seeking an improvement in their visual performance with a special focus on presbyopia correction.
Read the detailed description
To compare the clinical performance, quality of vision and subjective outcomes between the extended depth of focus (EDOF) Mini Well Ready intraocular lens (IOL) and the diffractive trifocal PanOptix IOL, at 3 months following second eye implantation.
Statistical analysis
All data will be analyzed using the Statistical Package for the Social Sciences (SPSS) v23 (SPSS Inc., Chicago, IL, USA). Graphs will be made using SPSS and Microsoft Excel (Microsoft Corp., Redmond, WA, USA). Normality will be tested for using the Shapiro Wilk test. If the data is normal, an independent t test will be used for comparing the continuous variables between the groups. If the data is not normal, then we will utilize the Mann Whitney U test.
Sample size calculation
The sample size calculation was based on the mean binocular Uncorrected Near Visual Acuity (UNVA) tested at 40cm under photopic condition. A previous study on the same diffractive trifocal IOL revealed a binocular UNVA of 0.01 ± 0.087 logMAR (12). The anticipated mean value for Mini Well Toric Ready is 0.10 logMAR. Based on these assumptions, an alpha of 0.05 and power of 0.8, it was calculated a number of 15 patients implanted bilaterally for each group. Assuming a dropout rate of 20% on the primary outcome measure, this resulted in a total number of 36 bilateral patients, 18 each group.
Duration of the project: Six months to one year
- Conditions
- Cataract, Lenses, Visual Impairment
- Being tested
- Intraocular lens
- Keywords
- Cataract, Intraocular lenses, Trifocal intraocular lenses, Extended depth of focus intraocular lenses, Presbyopia
- Medical subject headings
- Cataract, Vision Disorders, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular lensDevice
Also called Phacoemulsifcation
Bilateral implantation of the same intraocular lens.
| Study group | Role | What they receive |
|---|---|---|
| Extended depth of focus intraocular lens | Experimental | Bilateral implantation of extended depth of focus intraocular lenses. Receives: Device: Intraocular lens |
| Trifocal intraocular lens | Active comparator | Bilateral implantation of trifocal intraocular lenses. Receives: Device: Intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near Visual Acuity (Corrected and Uncorrected)
40 cm
Measured: 3 months after bilateral implantation
Intermediate Visual Acuity (Corrected and Uncorrected)
66 cm
Measured: 3 months after bilateral implantation
Distance Visual Acuity (Corrected and Uncorrected)
4 m
Measured: 3 months after bilateral implantation
Secondary outcomes (5)
Defocus Curve
Evaluating presbyopia correction
Measured: 3 months after bilateral implantation
Objective Automated Refraction
Using a auto refractometer (Topcon KR-800, Tokyo, Japan)
Measured: 3 months after bilateral implantation
Contrast Sensitivity
At 2.5 m
Measured: 3 months after bilateral implantation
Higher Order Abberations
Using a Abberometer
Measured: 3 months after bilateral implantation
Halos and Glares
Using custom software provided by SIFI
Measured: 3 months after bilateral implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start5 Nov 2018 (estimated)
- Primary completion6 May 2019 (estimated)
- Study completion6 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Model description
- Participants will be randomly allocated to one of two arms: Trifocal or extended depth of focus intraocular lenses.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hashmanis Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SIFI SpA, Hashmanis Foundation
- Responsible party
- Sponsor
- Investigators
- Sharif Hashmani, FCPS, Principal investigator, Hashmanis Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726606
- Sponsor's protocol ID
- HASH00011
- Status last verified
- Oct 2018
- First submitted
- 29 Oct 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Two-armed, and Single Blind Trial Evaluating the Visual Performance and Quality of Vision After Bilateral Implantation of 2 Presbyopia Correcting Intraocular Lenses: Trifocal Versus Extended Depth of Focus
- ClinicalTrials.gov ID
- NCT03726606
- Acronym / sponsor ID
- HASH00011
- Conditions
- Cataract, Lenses, Visual Impairment
- Keywords
- Cataract, Intraocular lenses, Trifocal intraocular lenses, Extended depth of focus intraocular lenses, Presbyopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hashmanis HospitalUniversity, hospital or other
- Collaborators
- SIFI SpA, Hashmanis Foundation
- Study start
- 5 Nov 2018 (estimated)
- Primary completion
- 6 May 2019 (estimated)
- Study completion
- 6 May 2019 (estimated)
- First posted
- 31 Oct 2018 (actual)
- 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.
We are conducting a trial evaluating the performance of trifocal versus extended depth of focus intraocular lenses. These lenses will be implanted in otherwise healthy individuals with visual problems due to bilateral cataracts. Patients must be seeking an improvement in their visual performance with a special focus on presbyopia correction.
Detailed description
To compare the clinical performance, quality of vision and subjective outcomes between the extended depth of focus (EDOF) Mini Well Ready intraocular lens (IOL) and the diffractive trifocal PanOptix IOL, at 3 months following second eye implantation.
Statistical analysis
All data will be analyzed using the Statistical Package for the Social Sciences (SPSS) v23 (SPSS Inc., Chicago, IL, USA). Graphs will be made using SPSS and Microsoft Excel (Microsoft Corp., Redmond, WA, USA). Normality will be tested for using the Shapiro Wilk test. If the data is normal, an independent t test will be used for comparing the continuous variables between the groups. If the data is not normal, then we will utilize the Mann Whitney U test.
Sample size calculation
The sample size calculation was based on the mean binocular Uncorrected Near Visual Acuity (UNVA) tested at 40cm under photopic condition. A previous study on the same diffractive trifocal IOL revealed a binocular UNVA of 0.01 ± 0.087 logMAR (12). The anticipated mean value for Mini Well Toric Ready is 0.10 logMAR. Based on these assumptions, an alpha of 0.05 and power of 0.8, it was calculated a number of 15 patients implanted bilaterally for each group. Assuming a dropout rate of 20% on the primary outcome measure, this resulted in a total number of 36 bilateral patients, 18 each group.
Duration of the project: Six months to one year
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to one of two arms: Trifocal or extended depth of focus intraocular lenses.
| Arm | Type | Receives |
|---|---|---|
| Extended depth of focus intraocular lens | Experimental | Device: Intraocular lensBilateral implantation of extended depth of focus intraocular lenses. |
| Trifocal intraocular lens | Active comparator | Device: Intraocular lensBilateral implantation of trifocal intraocular lenses. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged 30 years of age or older
- Has bilateral cataracts with visual problems
- Is motivated for vision correction
Key exclusion criteria (12 listed)
- Any ocular pathology that could impair vision, for example:
- History of trauma
- History of ocular surgery
- Individuals having trouble understanding written or spoken language
- Those with dense cataracts causing problems with optical biometry
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 |
|---|---|---|
| Intraocular lensAlso: PhacoemulsifcationBilateral implantation of the same intraocular lens. | Device | Extended depth of focus intraocular lens, Trifocal intraocular lens |
Primary outcome
Near Visual Acuity (Corrected and Uncorrected)
Time frame: 3 months after bilateral implantation
40 cm
Intermediate Visual Acuity (Corrected and Uncorrected)
Time frame: 3 months after bilateral implantation
66 cm
Distance Visual Acuity (Corrected and Uncorrected)
Time frame: 3 months after bilateral implantation
4 m
5 secondary outcomes
Defocus Curve
Time frame: 3 months after bilateral implantation
Objective Automated Refraction
Time frame: 3 months after bilateral implantation
Contrast Sensitivity
Time frame: 3 months after bilateral implantation
Higher Order Abberations
Time frame: 3 months after bilateral implantation
Halos and Glares
Time frame: 3 months after bilateral implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
Sharif Hashmani, FCPS principal investigator
Hashmanis Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular lens in people with Cataract and Lenses, run by Hashmanis Hospital.
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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nauman Hashmani, MBBS (00923212828062, naumanhashmani@hashmanis.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near Visual Acuity (Corrected and Uncorrected) (time frame: 3 months after bilateral implantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2018.