Comparison of Visual Outcomes After Implantation of the POD FT and the POD F (PoyPODF/FT)

June 29, 2021 updated by: Beaver-Visitec International, Inc.

Comparison of Visual Outcomes After Implantation of the POD 26P AY FT (PhysIOL) and the POD 26P AY F (PhysIOL)

There is no difference of the photic phenomena in the two groups.

The study will be a prospective non-randomised controlled study. The target is then to determine the equivalence in the glare. Assumption of Type I error is p=0.05 as level of significance and Type II error is alpha=0.8 as power.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be a prospective non-randomised controlled study. The target is then to determine the equivalence in the glare. Assumption of Type I error is p=0.05 as level of significance and Type II error is alpha=0.8 as power.

We used the 'TrialSize' package of the R software. Here are the parameters defined for the sample size calculation:

  1. Alpha: 0.05
  2. Power : 0.90
  3. Two sided test
  4. Equal group allocation
  5. Standard deviation for the two groups (POD 26P AY F et POD 26P AY FT) equal to 0.10
  6. Expected mean for the two groups (POD 26P AY F et POD 26P AY FT) equal to 0.89 (true difference between the means equal 0)
  7. An equivalence limit of 0.05, 0.10 and 0.15 Equivalence limit: 0.15 In order to show no difference between these two groups, 12 patients by groups are needed. With a drop-out of 15%, we obtain 30 patients (15 patients by group) to recruit in order to obtain 24 valuable patients.

Equivalence limit: 0.10 In order to show no difference between these two groups, 26 patients by groups are needed. With a drop-out of 15%, we obtain 62 patients (31 patients by group) to recruit in order to obtain 52 valuable patients.

This total number of subjects with such requirement is 26 patients in each group.

Group 1 will be made of 26 patients with corneal astigmatism higher than 1.0D in both eyes and lower than 2.5D and will be implanted with the POD 26P AY FT and Group 2 will be made of 26 patients with corneal astigmatism lower than 1.0D in both eyes.

Interim analysis after the 12th patient of each group will have completed the last follow-up will be achieved to confirm the equivalence with the equivalence limit of 0.15.

The POD platform in 26 % (non toric version) is available since 2008 in the monofocal version and since 2012 in the toric one (POD 6P AY T, Ankoris®, PhysIOL).The so-called POD design is characterised by two symmetrical bifid haptics with opened loops that provide four points of support to ensure IOL stability in the capsular bag. The dual C-loop profile shortens the loops, thus improving the pliability of the implant during its injection through a micro-incision. These shortened loops should permit a clockwise or anticlockwise rotary motion and should facilitate the comfortable fitting of the implant orientation after unfolding without elastic-restoring torque. The double C-loop POD design offers 4 support points for the implant within the capsule and ensures its stability. The V-shape of the upper and lower haptics together with the flexibility of the implant allow the loop separation angle to be adjusted and ensure the most accurate adaptation to the capsular bag size. A finite element structural analysis of the implant showed that the elasticity at the distal part of the loop prevents the constraints from being transmitted onto the optical portion of the implant. The trifocal optic is associated to the POD platform and is made of 26 % raw material.

The rotational stability of this non toric version has been clinically investigated on 117 consecutive eyes 1 week, 3 weeks, 3 and 12 months after implantation. The absolute rotation of the lens averaged 2.5 ± 2.6°. The position of the center of the implant relative to the pupillary center expressed by a vector was 0.01 mm at 70°.

The investigational product (POD 26P AY FT) is CE labeled since January 2014. Main IOL features are:

  • Biconvex toric aspheric (-0.11um SA) blue-blocking, hydrophilic acrylic IOL with 26% equlibrium water content, implantable through ≥ 2.2mm incision.
  • 4-point haptic design
  • 6 mm of optical diameter / 11.4 mm of total diameter
  • Dioptric range (SE): 6 to 35 D by 0.5 D increments
  • Cylinders at the IOL plane: 1, 1.5, 2.25, 3, 3.75, 4.5, 5.25, 6 D
  • Addition +1.75D / +3.5 D

The control product (POD 26P AY F) is CE labeled since 2010. Main IOL features are:

  • Biconvex, aspheric (-0.11um SA) blue-blocking, hydrophilic acrylic IOL with 26% equlibrium water content, implantable through ≥ 2.2mm incision.
  • 4-point haptics design which minimizes decentration and optimizes the rotational stability
  • 6 mm of optical diameter / 11.4 mm of total diameter
  • Dioptric range (SE): 6 to 35 D by 0.5 D increments
  • Addition +1.75D / +3.5 D

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients undergoing routine cataract surgery. The study participants receive a bilateral implantation of trifocal intraocular lenses. Depending on the preoperative corneal astigmatism, the patients receive either non-toric trifocal IOLs (POD F) or toric trifocal IOLs (POD FT) in both eyes.

Description

Inclusion Criteria:

  • Age-related cataract
  • Preoperative Corneal astigmatism < 0.75 D
  • Age 21 and older
  • Visual Acuity > 0.05
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
  • Patient willing multifocal implantation and with realistic expectations.

Exclusion Criteria:

  • Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies, retinal pathology (diabetic maculopathy, myopic maculopathy, age related macular degeneration...)
  • Previous ocular surgery or trauma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
POD 26P AY FT
26 patients with corneal astigmatism higher than 1.0D in both eyes and lower than 2.5D and will be implanted with the POD 26P AY FT
Device: POD 26P AY FT
Routine cataract surgery
POD 26P AY F
26 patients with corneal astigmatism lower than 1.0D in both eyes will be implanted with the POD 26P AY F
Device: POD 26P AY F
Routine cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the equivalence of the glare
Time Frame: 3 Months
The primary endpoint is to show statistically equivalent outcomes on glare at the 3 months follow up visit. A significance level of p = 0.05 will be considered statistically significant.
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of far, intermediate and near visual acuity
Time Frame: 6 Months
The secondary objective is to measure far, intermediate and near visual acuity of the POD AY 26P FT with respect to the POD AY 26P F.
6 Months
Refraction
Time Frame: 6 Months
The secondary objective is to measure the refraction of the POD AY 26P FT with respect to the POD AY 26P F.
6 Months
Centration
Time Frame: 6 Months
The secondary objective is to measure the centration of the POD AY 26P FT with respect to the POD AY 26P F.
6 Months
Rotational stability
Time Frame: 6 Months
The secondary objective is to measure the rotational stability of the POD AY 26P FT with respect to the POD AY 26P F.
6 Months
Equivalence of the visual acuity and the contrast sensitivity
Time Frame: 6 Months
The secondary objective is to determine the equivalence of the visual acuity of the POD AY 26P FT with respect to the POD AY 26P F.
6 Months
Equivalence of the visual acuity and the contrast sensitivity
Time Frame: 6 Months
The secondary objective is to determine the contrast sensitivity at far of the POD AY 26P FT with respect to the POD AY 26P F.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beaver-Visitec International, Inc.

Investigators

  • Principal Investigator: Francisco Poyales Galan, PhD, CEIC Hospital Clinical San Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2014

Primary Completion (Actual)

July 20, 2017

Study Completion (Actual)

July 20, 2017

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Poyales/POD FT - POD F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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