## Protocol Section
### Identification Module
**NCT ID:** NCT04465279

**Brief Title:** Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification

**Official Title:** Evaluation of Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification

#### Organization Study ID Info
**ID:** 0000755
#### Organization
**Class:** OTHER
**Full Name:** Alexandria University
### Status Module
#### Completion Date
**Date:** 2020-06-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-07-10

**Type:** ACTUAL

**Last Update Submit Date:** 2020-07-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-05-15

**Type:** ACTUAL

#### Start Date
**Date:** 2018-10-15

**Type:** ACTUAL

**Status Verified Date:** 2020-06

#### Study First Post Date
**Date:** 2020-07-10
**Type:** ACTUAL
**Study First Submit Date:** 2020-06-28
**Study First Submit QC Date:** 2020-07-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Alexandria University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** Monofocal IOLs, which provide effective distance vision, currently account for the majority of IOLs implantations. Patients who have undergone cataract surgery with implantation of monofocal IOL may require spectacles to perform near-distance (e.g., reading) or intermediate-distance (e.g., using a computer) tasks depending on their visual demandsMultifocal 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 Module

**Conditions:**

- Refractive Errors

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

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

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ACTUAL

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 36 eyes having implantation of trifocal diffractive IOL (FineVision)

**Intervention Names:**

- Device: Trifocal diffractive intraocular lens

**Label:** Trifocal Diffractive Intraocular Lens (FineVision)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Trifocal Diffractive Intraocular Lens (FineVision)

**Description:** 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.

**Name:** Trifocal diffractive intraocular lens

**Other Names:**

- (FineVision IOL)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Visual Acuity

**Time Frame:** 3 months

**Description:** 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

**Measure:** Defocus curve

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** using the CSV-1000 contrast test.

**Measure:** Contrast sensitivity

**Time Frame:** 3 months

**Description:** Questionnaire patient satisfaction protocol mediated by (PhysIOL Lige, Belgium).

**Measure:** Visual Satisfaction Questionnaire

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* 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).

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Alexandria

**Country:** Egypt

**Facility:** Alexandria Faculty of Medicine

#### Overall Officials

**Official 1:**

**Affiliation:** Alexandria Faculty of Medicine

**Name:** Ehab Mossallam, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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 Section

### Condition Browse Module - Ancestors

- ID: D000007905

- Term: Lens Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5638

- Name: Cataract

- Relevance: HIGH

- As Found: Cataract

- ID: M14872

- Name: Refractive Errors

- Relevance: HIGH

- As Found: Refractive Errors

- ID: M29066

- Name: Capsule Opacification

- Relevance: HIGH

- As Found: After Cataract

- ID: M10917

- Name: Lens Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002386

- Term: Cataract

- ID: D000012030

- Term: Refractive Errors

- ID: D000058442

- Term: Capsule Opacification

### Misc Info Module

- Version Holder: 2024-05-24
