Back to resultsClinical Outcomes With a New Monofocal IOL Enhanced for Intermediate Vision
Primary Purpose
Presbyopia
Status
Unknown status
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
phacoemulsification
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia
Eligibility Criteria
Inclusion Criteria:
- normal ocular examination apart from cataract.
Exclusion Criteria:
- 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).
Sites / Locations
- Daralshifa hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Assessment of intermediate vision, defocus curve
Arm Description
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.
Outcomes
Primary Outcome Measures
intermediate vision assessment
Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 80 cm .
near vision assessment
Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 40 cm.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04904887
Brief Title
Clinical Outcomes With a New Monofocal IOL Enhanced for Intermediate Vision
Official Title
Clinical Outcomes With a New Monofocal Intraocular Lens Enhanced for Intermediate Vision
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dar Al Shifa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
phacoemulsification with insertion of EYHANCE IOL to improve near and intermediate vision
Detailed Description
insertion of new intraocular lens enhanced for intermediate vision
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Assessment of intermediate vision, defocus curve
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification
Intervention Description
phacoemulsification with implantation of EYEHANCE IOL
Primary Outcome Measure Information:
Title
intermediate vision assessment
Description
Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 80 cm .
Time Frame
6 months postoperatively
Title
near vision assessment
Description
Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 40 cm.
Time Frame
6 months postoperatively
Secondary Outcome Measure Information:
Title
defocus curve
Description
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.
Time Frame
6 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
normal ocular examination apart from cataract.
Exclusion Criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magda Torky
Phone
0096594492487
Email
magda_turkey@yahoo.com
Facility Information:
Facility Name
Daralshifa hospital
City
Kuwait
Country
Kuwait
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
magda torky
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Outcomes With a New Monofocal IOL Enhanced for Intermediate Vision
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