A Comparison of the Visual Performance of Trifocal Versus Extended Depth of Focus Intraocular Lenses

• Sponsor: Hashmanis Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03726606
• Collaborator: SIFI SpA (Industry), Hashmanis Foundation (Other)
• Enrollment: 36
• Arms: 2
• Anticipated Duration (Months): 6

Study Details

Study Description

Brief 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. Patients must be seeking an improvement in their visual performance with a special focus on presbyopia correction.

Condition or Disease	Intervention/Treatment	Phase
Cataract; Lenses; Visual Impairment	Device: Intraocular lens	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomly allocated to one of two arms: Trifocal or extended depth of focus intraocular lenses.Participants will be randomly allocated to one of two arms: Trifocal or extended depth of focus intraocular lenses.
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: The patient and the examiner will be blinded to the arms.
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Nov 5, 2018
• Anticipated Primary Completion Date: May 6, 2019
• Anticipated Study Completion Date: May 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Extended depth of focus intraocular lens Bilateral implantation of extended depth of focus intraocular lenses.	Device: Intraocular lens; Bilateral implantation of the same intraocular lens.; Other Names: Phacoemulsifcation
Active Comparator: Trifocal intraocular lens Bilateral implantation of trifocal intraocular lenses.	Device: Intraocular lens; Bilateral implantation of the same intraocular lens.; Other Names: Phacoemulsifcation

Outcome Measures

Primary Outcome Measures

1. Near Visual Acuity (Corrected and Uncorrected) [3 months after bilateral implantation]

   40 cm

2. Intermediate Visual Acuity (Corrected and Uncorrected) [3 months after bilateral implantation]

   66 cm

3. Distance Visual Acuity (Corrected and Uncorrected) [3 months after bilateral implantation]

   4 m

Secondary Outcome Measures

1. Defocus Curve [3 months after bilateral implantation]

   Evaluating presbyopia correction

2. Objective Automated Refraction [3 months after bilateral implantation]

   Using a auto refractometer (Topcon KR-800, Tokyo, Japan)

3. Contrast Sensitivity [3 months after bilateral implantation]

   At 2.5 m

4. Higher Order Abberations [3 months after bilateral implantation]

   Using a Abberometer

5. Halos and Glares [3 months after bilateral implantation]

   Using custom software provided by SIFI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient aged 30 years of age or older

• Has bilateral cataracts with visual problems

• Is motivated for vision correction

Exclusion Criteria:

• 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

• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hashmanis Hospital
• SIFI SpA
• Hashmanis Foundation

Investigators

• Principal Investigator: Sharif Hashmani, FCPS, Hashmanis Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hashmanis Hospital
• ClinicalTrials.gov Identifier: NCT03726606
• Other Study ID Numbers: HASH00011
• First Posted: Oct 31, 2018
• Last Update Posted: Oct 31, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hashmanis Hospital: Cataract; Intraocular lenses; Trifocal intraocular lenses; Extended depth of focus intraocular lenses; Presbyopia
• Additional relevant MeSH terms: Vision Disorders; Vision, Low; Cataract

Study Results

No Results Posted as of Oct 31, 2018