Lenses, IntraocularNCT05430295
Visual Acuity After Using A New Monofocal Intraocular Lens Compared To Standard Monofocal Lens
A study testing phacoemulsification and monofocal intraocular lens implantation in people with Lenses, Intraocular, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. Twenty patients (20) were enrolled in this study 10 patients in each group. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lenses, Intraocular
- What is being tested?
- phacoemulsification and monofocal intraocular lens implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Nov 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 50-75 years old undergoing cataract surgery.
- Preoperative corneal astigmatism equal to or less than - 1.00 D.
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
Who cannot join
- Visual potential of less than 0.63 due to ocular pathologies.
- Corneal astigmatism over -1.00 D cylinder.
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions).
- Capsule or zonular abnormalities that would affect postoperative centration or tilt of the lens and pseudoexfoliation syndrome.
- Macular degeneration, cystoid macular edema,Diabetic retinopathy, history of uveitis, optic nerve diseases, glaucoma and amblyopia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distance And Intermediate Visual Acuity After Phacoemulsification Using A New Generation Monofocal Intraocular Lens Compared To Standard Monofocal Intraocular Lens
This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. Twenty patients (20) were enrolled in this study 10 patients in each group. It was designed for comparison of uncorrected and best corrected distance and intermediate vision in patients whom implanted with monofocal Tecnis Eyhance or Tecnis 1-piece IOLs.
Read the detailed description
Purpose To determine the Uncorrected and best-corrected distance, and intermediate visual acuity in a new innovative monofocal intraocular lens compared with standard monofocal lens.
Methods This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. 40 eyes of Twenty patients (20) were enrolled in this study, patients who are candidates for cataract extraction by phacoemulsification were included in this study and underwent thorough preoperative examination and post-operative evaluation at 3 months after the 2nd eye operation, of distance, intermediate, near add, contrast sensitivity and incidence of photic phenomena using a printed questionnaire for evaluating this incidence and binocular defocus curves were analyzed.
- Conditions
- Lenses, Intraocular
- Being tested
- phacoemulsification, monofocal intraocular lens implantation
- Keywords
- intraocular lens, intermediate vision, contrast sensitivity, monofocal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsificationProcedure or surgery
Also called cataract extraction
cataract extraction followed by bilateral implantation of Eyhance intraocular lens in 10 patients and bilateral implantation of Tecnis 1 piece IOL in 10 patients
monofocal intraocular lens implantationProcedure or surgery
implantation of monofocal intraocular lens in the capsular bag at the end of phacoemulsification surgery
| Study group | Role | What they receive |
|---|---|---|
| Eyhance intraocular lens | Active comparator | 10 patients bilaterally implanted with Eyhance intraocular lens Receives: Procedure: phacoemulsification; Procedure: monofocal intraocular lens implantation |
| Tecnis 1 piece intraocular lens | Active comparator | 10 patients bilaterally implanted with Tecnis 1 piece intraocular lens Receives: Procedure: phacoemulsification; Procedure: monofocal intraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected and best-corrected distance, and intermediate visual acuity.
Distance visual acuities were examined by ETDRS chart and intermediate and near visual acuity by Jaeger chart at 66 cm and 33 cm respectively.Measured values of the visual acuity were expressed in decimal values and converted to logMAR values.
Measured: 3 months post operative
Secondary outcomes (1)
Contrast sensitivity
Contrast sensitivity was measured using Pelli Robson illuminated chart at 1m
Measured: 3 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jan 2021
- Primary completion1 Aug 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lenses, 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective comparative interventional clinical study,
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rokaya Emad Radwan, Kasr El Aini Hospital
- Investigators
- yehia Salaheldin, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430295
- Sponsor's protocol ID
- MS-239-2021
- Status last verified
- Sep 2022
- First submitted
- 13 Apr 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: the data of the patients are kept in files with the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distance And Intermediate Visual Acuity After Phacoemulsification Using A New Generation Monofocal Intraocular Lens Compared To Standard Monofocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT05430295
- Acronym / sponsor ID
- MS-239-2021
- Conditions
- Lenses, Intraocular
- Keywords
- intraocular lens, intermediate vision, contrast sensitivity, monofocal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 24 Jun 2022 (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.
This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. Twenty patients (20) were enrolled in this study 10 patients in each group. It was designed for comparison of uncorrected and best corrected distance and intermediate vision in patients whom implanted with monofocal Tecnis Eyhance or Tecnis 1-piece IOLs.
Detailed description
Purpose To determine the Uncorrected and best-corrected distance, and intermediate visual acuity in a new innovative monofocal intraocular lens compared with standard monofocal lens.
Methods This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. 40 eyes of Twenty patients (20) were enrolled in this study, patients who are candidates for cataract extraction by phacoemulsification were included in this study and underwent thorough preoperative examination and post-operative evaluation at 3 months after the 2nd eye operation, of distance, intermediate, near add, contrast sensitivity and incidence of photic phenomena using a printed questionnaire for evaluating this incidence and binocular defocus curves were analyzed.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective comparative interventional clinical study,
| Arm | Type | Receives |
|---|---|---|
| Eyhance intraocular lens | Active comparator | Procedure: phacoemulsification, Procedure: monofocal intraocular lens implantation10 patients bilaterally implanted with Eyhance intraocular lens |
| Tecnis 1 piece intraocular lens | Active comparator | Procedure: phacoemulsification, Procedure: monofocal intraocular lens implantation10 patients bilaterally implanted with Tecnis 1 piece intraocular lens |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 50-75 years old undergoing cataract surgery.
- Preoperative corneal astigmatism equal to or less than - 1.00 D.
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
Key exclusion criteria (5 listed)
- Visual potential of less than 0.63 due to ocular pathologies.
- Corneal astigmatism over -1.00 D cylinder.
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions).
- Capsule or zonular abnormalities that would affect postoperative centration or tilt of the lens and pseudoexfoliation syndrome.
- Macular degeneration, cystoid macular edema,Diabetic retinopathy, history of uveitis, optic nerve diseases, glaucoma and amblyopia.
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 |
|---|---|---|
| phacoemulsificationAlso: cataract extractioncataract extraction followed by bilateral implantation of Eyhance intraocular lens in 10 patients and bilateral implantation of Tecnis 1 piece IOL in 10 patients | Procedure or surgery | Eyhance intraocular lens, Tecnis 1 piece intraocular lens |
| monofocal intraocular lens implantationimplantation of monofocal intraocular lens in the capsular bag at the end of phacoemulsification surgery | Procedure or surgery | Eyhance intraocular lens, Tecnis 1 piece intraocular lens |
Primary outcome
Uncorrected and best-corrected distance, and intermediate visual acuity.
Time frame: 3 months post operative
Distance visual acuities were examined by ETDRS chart and intermediate and near visual acuity by Jaeger chart at 66 cm and 33 cm respectively.Measured values of the visual acuity were expressed in decimal values and converted to logMAR values.
1 secondary outcome
Contrast sensitivity
Time frame: 3 months post operative
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 27 Sep 2022.
- Individual participant dataSharing planned: No. the data of the patients are kept in files with the principal investigator
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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.
yehia Salaheldin, PhD study director
Cairo University
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 and monofocal intraocular lens implantation in people with Lenses, Intraocular, run by Kasr El Aini Hospital at 1 site in Egypt.
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 5 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 27 Sep 2022. 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 Egypt. 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?
Uncorrected and best-corrected distance, and intermediate visual acuity. (time frame: 3 months post operative). 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 Sep 2022.