PresbyopiaNCT04904887
Clinical Outcomes With a New Monofocal IOL Enhanced for Intermediate Vision
A study testing phacoemulsification in people with Presbyopia, run by Dar Al Shifa Hospital at 1 site in Kuwait.
Trial summary
phacoemulsification with insertion of EYHANCE IOL to improve near and intermediate vision Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Nov 2020to 30 Oct 2021
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- normal ocular examination apart from cataract.
Who cannot join
- previous ocular surgery.
- ocular pathology or corneal abnormalities.
- 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.
Kuwait1 site, 1 recruiting
- Recruiting
Daralshifa hospital
Kuwait City
magda torky
About this study
Official title: Clinical Outcomes With a New Monofocal Intraocular Lens Enhanced for Intermediate Vision
phacoemulsification with insertion of EYHANCE IOL to improve near and intermediate vision
Read the detailed description
insertion of new intraocular lens enhanced for intermediate vision
- Conditions
- Presbyopia
- Being tested
- phacoemulsification
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsificationProcedure or surgery
phacoemulsification with implantation of EYEHANCE IOL
| Study group | Role | What they receive |
|---|---|---|
| Assessment of intermediate vision, defocus curve | Other | Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 4 m, 80 cm, and 40 cm.
he binocular 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. Receives: Procedure: phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
intermediate vision assessment
Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 80 cm .
Measured: 6 months postoperatively
near vision assessment
Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 40 cm.
Measured: 6 months postoperatively
Secondary outcomes (1)
defocus curve
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Nov 2020
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- patients undergoing cataract surgery are managed with phacoemulsification and insertion of Eyehance intraocular lens in order to improve their intermediate vision.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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
- NCT04904887
- Sponsor's protocol ID
- 02282021065725
- Status last verified
- May 2021
- First submitted
- 21 May 2021
- Last updated
- 27 May 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 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes With a New Monofocal Intraocular Lens Enhanced for Intermediate Vision
- ClinicalTrials.gov ID
- NCT04904887
- Acronym / sponsor ID
- 02282021065725
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dar Al Shifa HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 27 May 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.
phacoemulsification with insertion of EYHANCE IOL to improve near and intermediate vision
Detailed description
insertion of new intraocular lens enhanced for intermediate vision
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients undergoing cataract surgery are managed with phacoemulsification and insertion of Eyehance intraocular lens in order to improve their intermediate vision.
| Arm | Type | Receives |
|---|---|---|
| Assessment of intermediate vision, defocus curve | Other | Procedure: phacoemulsificationStandardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 4 m, 80 cm, and 40 cm. he binocular 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- normal ocular examination apart from cataract.
Key exclusion criteria (4 listed)
- previous ocular surgery.
- ocular pathology or corneal abnormalities.
- 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 |
|---|---|---|
| phacoemulsificationphacoemulsification with implantation of EYEHANCE IOL | Procedure or surgery | Assessment of intermediate vision, defocus curve |
Primary outcome
intermediate vision assessment
Time frame: 6 months postoperatively
Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 80 cm .
near vision assessment
Time frame: 6 months postoperatively
Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 40 cm.
1 secondary outcome
defocus curve
Time frame: 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 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.
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 in people with Presbyopia, 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: status not confirmed, as of the sponsor's last update on 27 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magda Torky (0096594492487, magda_turkey@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intermediate vision assessment (time frame: 6 months postoperatively). The study lists 2 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 27 May 2021.