Skip to main content
OpenTrials
Completed

NCT Number: NCT04618380

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Presbyopia Cataract Eye Diseases Lens Diseases Refractive Errors

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity

Diagnostic Test

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2020
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.