Loss of Visual Contrast SensitivityNCT04907955
Visual Performance Following Implantation of Presbyopia Correcting IOLs
A study testing phacoemulsification with implantation of presbyopia correcting IOL in people with Loss of Visual Contrast Sensitivity and Near Vision, run by Dar Al Shifa Hospital at 1 site in Kuwait.
Trial summary
The purpose of the current study was to compare the visual performance after bilateral implantation of the Panoptix IOL , or the AT LISA IOL or Tecnis Symfony IOL . The focus was on intermediate vision, defocus curves, and contrast sensitivity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Loss of Visual Contrast Sensitivity, Near Vision, Visual Impairment
- What is being tested?
- phacoemulsification with implantation of presbyopia correcting IOL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Jun 2019to 30 May 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with normal ocular examination apart from cataract.
Who cannot join
- previous ocular surgery.
- ocular pathology or corneal abnormalities.
- an endothelial cell count below 2000 cells/mm2.
- corneal astigmatism greater than 1.0 diopter (D) measured with Scheimpflug tomography (Sirius, CSO, Italy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visual Performance Following Implantation of 3 Presbyopia Correcting Intraocuar Lenses
The purpose of the current study was to compare the visual performance after bilateral implantation of the Panoptix IOL , or the AT LISA IOL or Tecnis Symfony IOL . The focus was on intermediate vision, defocus curves, and contrast sensitivity.
- Being tested
- phacoemulsification with implantation of presbyopia correcting IOL
- Medical subject headings
- Myopia, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsification with implantation of presbyopia correcting IOLProcedure or surgery
cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL
| Study group | Role | What they receive |
|---|---|---|
| panoptix PANFOCAL intraocular lens | Active comparator | panoptix PANFOCAL intraocular lensis a single-piece aspheric non-apodized diffractive panfocal IOL that distributes light energy to three focal points in both small and large pupil conditions Receives: Procedure: phacoemulsification with implantation of presbyopia correcting IOL |
| Trifocal Diffractive the AT LISA intraocular lens | Active comparator | Trifocal Diffractive the AT LISA is a preloaded single-piece aspheric diffractive trifocal IOL and made of hydrophilic acrylic with a hydrophobic surface with an ultraviolet absorber. This aspheric IOL is aberration -correcting in order to reduce and compensate for corneal spherical aberrations. Receives: Procedure: phacoemulsification with implantation of presbyopia correcting IOL |
| Symphony EDOF (extended depth of focus) intraocular lens | Active comparator | SYMPHONY EDOF intraocular lens is a single-piece aspheric biconvex hydrophobic acrylic IOL with a 6.0 mm optic and an 13.0 mm overall diameter. This IOL consists of a wavefront-designed anterior aspheric surface (negative spherical aberration of -0.27 mm to counterbalance the net positive spherical aberration from cornea) and a posterior achromatic diffractive surface with echelette design. Receives: Procedure: phacoemulsification with implantation of presbyopia correcting IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
The monocular uncorrected (UDVA) and corrected (CDVA) distance visual acuity (4 m), uncorrected intermediate visual acuity (UIVA) (60 cm and 80 cm), distance-corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (40 cm), and distance-corrected near visual acuity (DCNVA) were assessed. Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 4 m, 80 cm, and 40 cm.
Measured: 6 months postoperatively.
Secondary outcomes (4)
defocus curve
The binocular defocus curve was done to evaluate the functional range of vision. The curve was obtained while the patient wearing his distance correction to provide the best distance visual acuity in both eyes. The test was performed under photopic conditions (85 candelas/m2) using ETDRS charts at a distance of 4m with the introduction of defocusing lenses from +1.00 D to -4.00 D in 0.50 D steps.
Measured: 6 months postoperatively.
contract senstivity
The CSV-1000 system (Vector Vision Inc. Greenville, OH, USA) was used to measure contrast sensitivity under photopic and mesopic conditions without glare with spatial frequencies ranging between 3 and 18 cycles/degree.
Measured: 6 months postoperatively.
photic phenomena
The presence of dysphotopsia including haloes, glare and starburst were assessed regarding their frequency, severity and the degree of bother.
Measured: 6 months postoperatively.
spectacle independence
patients were given a questionnaire to assess their spectacle independence. The response for spectacle independence was yes or no.
Measured: 6 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Jun 2019
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loss of Visual Contrast SensitivityStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dar Al Shifa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, magda torky, Dar Al Shifa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907955
- Sponsor's protocol ID
- 02282021065727
- Status last verified
- May 2021
- First submitted
- 21 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Performance Following Implantation of 3 Presbyopia Correcting Intraocuar Lenses
- ClinicalTrials.gov ID
- NCT04907955
- Acronym / sponsor ID
- 02282021065727
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dar Al Shifa HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 1 Jun 2021 (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.
The purpose of the current study was to compare the visual performance after bilateral implantation of the Panoptix IOL , or the AT LISA IOL or Tecnis Symfony IOL . The focus was on intermediate vision, defocus curves, and contrast sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| panoptix PANFOCAL intraocular lens | Active comparator | Procedure: phacoemulsification with implantation of presbyopia correcting IOLpanoptix PANFOCAL intraocular lensis a single-piece aspheric non-apodized diffractive panfocal IOL that distributes light energy to three focal points in both small and large pupil conditions |
| Trifocal Diffractive the AT LISA intraocular lens | Active comparator | Procedure: phacoemulsification with implantation of presbyopia correcting IOLTrifocal Diffractive the AT LISA is a preloaded single-piece aspheric diffractive trifocal IOL and made of hydrophilic acrylic with a hydrophobic surface with an ultraviolet absorber. This aspheric IOL is aberration -correcting in order to reduce and compensate for corneal spherical aberrations. |
| Symphony EDOF (extended depth of focus) intraocular lens | Active comparator | Procedure: phacoemulsification with implantation of presbyopia correcting IOLSYMPHONY EDOF intraocular lens is a single-piece aspheric biconvex hydrophobic acrylic IOL with a 6.0 mm optic and an 13.0 mm overall diameter. This IOL consists of a wavefront-designed anterior aspheric surface (negative spherical aberration of -0.27 mm to counterbalance the net positive spherical aberration from cornea) and a posterior achromatic diffractive surface with echelette design. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with normal ocular examination apart from cataract.
Key exclusion criteria (4 listed)
- previous ocular surgery.
- ocular pathology or corneal abnormalities.
- an endothelial cell count below 2000 cells/mm2.
- corneal astigmatism greater than 1.0 diopter (D) measured with Scheimpflug tomography (Sirius, CSO, Italy).
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 |
|---|---|---|
| phacoemulsification with implantation of presbyopia correcting IOLcataract extraction with phacoemulsification and insertion of presbyopia correcting IOL | Procedure or surgery | Symphony EDOF (extended depth of focus) intraocular lens, Trifocal Diffractive the AT LISA intraocular lens, panoptix PANFOCAL intraocular lens |
Primary outcome
visual acuity
Time frame: 6 months postoperatively.
The monocular uncorrected (UDVA) and corrected (CDVA) distance visual acuity (4 m), uncorrected intermediate visual acuity (UIVA) (60 cm and 80 cm), distance-corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (40 cm), and distance-corrected near visual acuity (DCNVA) were assessed. Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 4 m, 80 cm, and 40 cm.
4 secondary outcomes
defocus curve
Time frame: 6 months postoperatively.
contract senstivity
Time frame: 6 months postoperatively.
photic phenomena
Time frame: 6 months postoperatively.
spectacle independence
Time frame: 6 months 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 1 Jun 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phacoemulsification with implantation of presbyopia correcting IOL in people with Loss of Visual Contrast Sensitivity and Near Vision, run by Dar Al Shifa Hospital at 1 site in Kuwait.
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 1 Jun 2021. 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 Kuwait. 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?
visual acuity (time frame: 6 months postoperatively.). 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 1 Jun 2021.