Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification

NCT04465279 | Completed Phase 2

• 1 other identifier: 0000755
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Multifocal IOLs that maintain distance focus and improve near vision have been developed to reduce spectacle dependence.Multifocal IOLs improve patient performance of near-vision tasks, such as reading crafts, hobbies, and social activities to a greater extent than do monofocal IOLs. However, halos and reduced contrast sensitivity have been associated with multifocal IOLs and are common reasons for patient's dissatisfaction.Trifocal technology has been developed to create intermediate focus to overcome these difficulties. Continuous reports of the visual outcomes of the FineVision trifocal IOLs are encouraging.

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (2)

• Visual Acuity

  Current study used Sloan chart (Good - Lite Co, USA) for intermediate, Snellen chart for far and Landolt ring chart for near vision

  3 months

• Defocus curve

  examined monocular and binocular after correcting distant VA refractive error then inserting defocus lenses 0.50-D focus steps from (+1.50 to -3.50 D) in the trial frame

  3 months

Secondary Outcomes (2)

• Contrast sensitivity

  3 months

• Visual Satisfaction Questionnaire

  3 months

Study Arms (1)

Trifocal Diffractive Intraocular Lens (FineVision)

EXPERIMENTAL

36 eyes having implantation of trifocal diffractive IOL (FineVision)

Device: Trifocal diffractive intraocular lens

Interventions

Trifocal diffractive intraocular lens DEVICE

Trifocal IOL having foldable single-piece fully diffractive pupil dependent aspheric IOL. Which have been made of hydrophilic acrylic with an ultraviolet (UV) and blue light inhibitor. It has an optic diameter of 6.15 mm and an overall diameter of 10.75 mm; it has +3.5D additional power for near vision and +1.75 D additional power for intermediate vision, consisting of 26 diffractive steps.

Also known as: (FineVision IOL)

Trifocal Diffractive Intraocular Lens (FineVision)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient eyes had cataract with no other pathology, patients desire for spectacle independence after surgery and with realistic expectation.

You may not qualify if:

• Any ocular comorbidity that affect the end results of the surgery, history of ocular trauma, irregular corneal astigmatism, pupil abnormalities and capsular or zonular abnormalities that may affect postoperative centration as tilt of the lens (e.g. pseudo exfoliation syndrome and Marfan's syndrome).

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, Egypt

Location

Related Publications (1)

• Zein El-Dein AA, Elmassry A, El-Hennawi HM, Mossallam EF. Objective and subjective evaluation of trifocal diffractive intraocular Lens after cataract extraction with phacoemulsification: a prospective clinical study. BMC Ophthalmol. 2021 Apr 14;21(1):179. doi: 10.1186/s12886-021-01937-z.

  PMID: 33849466 DERIVED

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Ehab Mossallam, PhD

  Alexandria Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, non-comparative, non-randomized study including 36 eyes had implantation of trifocal diffractive IOL

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 10, 2020
• Study Start: October 15, 2018
• Primary Completion: May 15, 2020
• Study Completion: June 15, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)