Premium Monovision Versus Other Types of Monovision and Bilateral Trifocal Implantation.

November 5, 2020 updated by: Georgios Labiris, Democritus University of Thrace

Premium Monovision Versus Bilateral Myopic Monovision, Hybrid Monovision and Bilateral Trifocal Implantation. A Comparative Study.

Primary objective of this study was to compare the efficacy of premium monovision with Restor and Panoptix, against other prevalent monovision techniques and against bilateral Panoptix implantation in a sample of patients following lens-extraction surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Four study groups were formed according to the procedure and the intraocular lens technology that was used: a) Monovision Group (MoG), b) Multifocal Lens Group (MfG), c) Hybrid Monovision Group (HmG), and, d) Premium Monovision Group (PmG). Patients who have undergone one of the above categories of presbyopia correction surgery were selected to compare the effectiveness of these techniques by evaluating the uncorrected near, intermediate and distant visual acuity as well as the degree of subjective patient satisfaction, contrast sensitivity, dysphotopsia symptoms and spectacle independence .

Study Type

Observational

Enrollment (Actual)

120

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

  • Greece
    • Evros
      • Alexandroupolis, Evros, Greece, 68100
        • Department of Ophthalmology, University Hospital of Alexandroupolis

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants were recruited from the Cataract Service of the University Hospital of Alexandroupolis in a consecutive-if-eligible basis.

Description

Inclusion Criteria:

  • Diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion Criteria:

  • Manifest astigmatism > 1.00 diopters
  • Reports of headaches and/or eyestrain associated with visual activities
  • Positive, pathologic ocular cover test (near & distant) and / or the Mallett's disparity test (near & distant) and the double Maddox rod test
  • Endothelial cell count less than 1900/mm2
  • Glaucoma
  • intraocular pressure-lowering medications
  • Former incisional surgery
  • Former diagnosis of corneal disease
  • Former diagnosis of fundus disease
  • Diabetes
  • Autoimmune diseases
  • Mental diseases

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bilateral trifocal implantation
Bilateral implantation of trifocal diffractive intraocular lenses (Panoptix, Alcon) targeting emmetropia
Diagnostic test: bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity

The following clinical indexes are evaluated:

  1. Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance
  2. Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and
  3. Binocular uncorrected critical print size at 60cm (bUI-CPS) and at 40cm (bUN-CPS).

All near and intermediate vision parameters are obtained using the Democritus Digital Acuity Reading Test (DDART), which is based on the Greek version of MNREAD.

Contrast sensitivity are evaluated with the Pelli-Robson test.
Myopic monovision
The dominant eye defocus is targeted to -0.50 diopters while the recessive one to -1.25 diopters with bilateral implantation of monofocal intraocular lenses (SN60WF, Alcon)
Diagnostic test: bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity

The following clinical indexes are evaluated:

  1. Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance
  2. Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and
  3. Binocular uncorrected critical print size at 60cm (bUI-CPS) and at 40cm (bUN-CPS).

All near and intermediate vision parameters are obtained using the Democritus Digital Acuity Reading Test (DDART), which is based on the Greek version of MNREAD.

Contrast sensitivity are evaluated with the Pelli-Robson test.
Hybrid monovision
Hybrid monovision combines a monofocal intraocular (SN60WF, Alcon) in the dominant eye and a trifocal diffractive intraocular lens (Panoptix, Alcon) in the recessive one
Diagnostic test: bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity

The following clinical indexes are evaluated:

  1. Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance
  2. Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and
  3. Binocular uncorrected critical print size at 60cm (bUI-CPS) and at 40cm (bUN-CPS).

All near and intermediate vision parameters are obtained using the Democritus Digital Acuity Reading Test (DDART), which is based on the Greek version of MNREAD.

Contrast sensitivity are evaluated with the Pelli-Robson test.
Premium monovision
Participants received a bifocal hybrid (refractive at the centre, diffractive at the periphery) intraocular lens (Restor +2.50 diopters, Alcon) in the dominant eye and a trifocal diffractive intraocular lens (Panoptix, Alcon) in the recessive one, targeting emmetropia in both eyes.
Diagnostic test: bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity

The following clinical indexes are evaluated:

  1. Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance
  2. Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and
  3. Binocular uncorrected critical print size at 60cm (bUI-CPS) and at 40cm (bUN-CPS).

All near and intermediate vision parameters are obtained using the Democritus Digital Acuity Reading Test (DDART), which is based on the Greek version of MNREAD.

Contrast sensitivity are evaluated with the Pelli-Robson test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binocular uncorrected distant visual acuity [bUD-VA]
Time Frame: through study completion, an average of 2.5years
bUD-VA is obtained using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance. This parameter is obtained six months following the operation of the second eye.
through study completion, an average of 2.5years
Binocular uncorrected intermediate reading acuity (at 60cm) [bUI-RA)]
Time Frame: through study completion, an average of 2.5years
bUI-RA is obtained using the DDART reading test, which is based on the Greek version of MNREAD. This parameter is obtained six months following the operation of the second eye.
through study completion, an average of 2.5years
binocular uncorrected near reading acuity (at 40cm) [bUN-RA]
Time Frame: through study completion, an average of 2.5years
bUN-RA is obtained using the DDART reading test, which is based on the Greek version of MNREAD. This parameter is obtained six months following the operation of the second eye.
through study completion, an average of 2.5years
binocular uncorrected intermediate critical print size (at 60cm) [bUI-CPS]
Time Frame: through study completion, an average of 2.5years
bUI-CPS is obtained using the DDART reading test, which is based on the Greek version of MNREAD. This parameter is obtained six months following the operation of the second eye.
through study completion, an average of 2.5years
binocular uncorrected near critical print size (at 40cm )[bUN-CPS]
Time Frame: through study completion, an average of 2.5years
bUN-CPS is obtained using the DDART reading test, which is based on the Greek version of MNREAD. This parameter is obtained six months following the operation of the second eye.
through study completion, an average of 2.5years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysphotopsia symptoms
Time Frame: through study completion, an average of 2.5years
Dysphotopsia is evaluated with two direct 4-scale, Likert-type questions (Always, Most of the times, Sometimes, Never) pertaining on the subjective perception of glare and unwanted shadows. This parameter is obtained six months following the operation of the second eye.
through study completion, an average of 2.5years
Contrast sensitivity
Time Frame: through study completion, an average of 2.5years
Contrast sensitivity is evaluated with the Pelli-Robson test. This parameter is obtained six months following the operation of the second eye.
through study completion, an average of 2.5years
Spectacle independence
Time Frame: through study completion, an average of 2.5years
Spectacle dependence is also evaluated for both distant and near vision by two direct 4-scale Likert-type questions (Always, Most of the times, Sometimes, Never). This parameter is obtained six months following the operation of the second eye.
through study completion, an average of 2.5years
Subjective satisfaction using Visual Function Index (VF-14 instrument) (total score, VF14-NV score & VF14-DV score)
Time Frame: through study completion, an average of 2.5years

Subjective satisfaction rates are assessed using the prevalent VF-14 instrument. Further to the total VF-14 score assessment, two additional scores are calculated: a) Near vision VF score (VF14-NV) derived from items that assess the perceived difficulty in near vision activities (items 1,2,3,7,8,9 and 11), and, b) Distant vision VF score (VF14-DV) derived from items that assess the perceived difficulty of distant vision activities (items 4, 5, 6, 10, 12, 13 and 14).

VF-14 has a final score from 0 to 100. A score of 100 indicates able to do all applicable activities. A score of 0 indicates unable to do all applicable activities because of vision.
through study completion, an average of 2.5years

Collaborators and Investigators

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

Sponsor

Democritus University of Thrace

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)

January 1, 2018

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

November 1, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES13/Th9/22-10-2020

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.

Subscribe