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

Sponsor
Democritus University of Thrace (Other)
Overall Status
Completed
CT.gov ID
NCT04618380
Collaborator
(none)
120
Enrollment
1
Location
34
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Premium Monovision Versus Bilateral Myopic Monovision, Hybrid Monovision and Bilateral Trifocal Implantation. A Comparative Study.
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Jul 31, 2020
Actual Study Completion Date :
Nov 1, 2020

Arms and Interventions

ArmIntervention/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: Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and 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: Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and 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: Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and 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: Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and 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.

Outcome Measures

Primary Outcome Measures

  1. Binocular uncorrected distant visual acuity [bUD-VA] [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.

  2. Binocular uncorrected intermediate reading acuity (at 60cm) [bUI-RA)] [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.

  3. binocular uncorrected near reading acuity (at 40cm) [bUN-RA] [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.

  4. binocular uncorrected intermediate critical print size (at 60cm) [bUI-CPS] [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.

  5. binocular uncorrected near critical print size (at 40cm )[bUN-CPS] [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.

Secondary Outcome Measures

  1. Dysphotopsia symptoms [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.

  2. Contrast sensitivity [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.

  3. Spectacle independence [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.

  4. Subjective satisfaction using Visual Function Index (VF-14 instrument) (total score, VF14-NV score & VF14-DV score) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Department of Ophthalmology, University Hospital of AlexandroupolisAlexandroupolisEvrosGreece68100

Sponsors and Collaborators

  • Democritus University of Thrace

Investigators

  • Study Chair: Georgios Labiris, MD,PHD, Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace
ClinicalTrials.gov Identifier:
NCT04618380
Other Study ID Numbers:
  • ES13/Th9/22-10-2020
First Posted:
Nov 5, 2020
Last Update Posted:
Nov 9, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2020