Skip to main content
OpenTrials
Completed

NCT Number: NCT05494177

Comparison of Premium Monovision and Bilateral Implantation of Trifocal Diffractive Intraocular Lenses

Primary objective of this study is to compare two presbyopia correction surgical techniques, specificaly premium monovision, in which the dominant eye is corrected with an extended depth of field intraocular lens and the non-dominant eye with a trifocal diffractive intraocular lens, and the bilateral implantation of trifocal diffractive intraocular lenses.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Presbyopia Cataract Eye Diseases Lens Diseases Refractive Errors

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

About this study

Two study groups will be formed. The first group will include patients who undergone premium monovision and the second will include patients who undergone bilateral implantation of trifocal diffractive intraocular lenses. Patients who have undergone one of the aforementioned categories of presbyopia correction surgery will be selected in order to compare the effectiveness of these techniques by evaluating uncorrected near, intermediate and distant visual acuity, uncorrected Critical Print Size (CPS) in near and intermediate distance, dysphotopic phenomena (glare, halos) through a 4-level severity scale by patients, contrast sensitivity, the need of use glasses for all distances or separately for activities requiring near or distant vision as well as the degree of subjective satisfaction of patient via interview (NEI-VFQ 25). The purpose of measuring these parameters is to calculate, through a mathematical model, the relative effectiveness of each method.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of cataract with stage 2 according to the Lens Opacities Classification System III (LOCS-3) grading scale
  • Age>45 years

Exclusion criteria

  • Disability to understand the Greek language and respond to the interview
  • Fundus or corneal diseases
  • Glaucoma
  • Previous intraocular surgery

Treatment and study plan

bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS

Diagnostic Test

All participants will be assessed on the following clinical indexes:

  • Binocular uncorrected distant visual acuity (bUDVA) at four meters distance
  • Binocular uncorrected intermediate reading acuity (bUIRA) at 60 cm
  • Binocular uncorrected near reading acuity (bUNVA) at 40 cm
  • Binocular uncorrected intermediate Critical Print Size (bUICPS) at 60 cm
  • Binocular uncorrected near Critical Print Size (bUNCPS) at 40 cm

All the above parameters are obtained using the Democritus Digital Acuity & Reading Test (DDART).

Contrast sensitivity

Diagnostic Test

Contrast sensitivity is assessed with the Pelli-Robson test.

Primary outcomes

  1. Binocular uncorrected distant visual acuity (bUDVA)

    Time frame: 1 year

    bUDVA is obtained using the distance vision test of DDART at four meters distance.

  2. Binocular uncorrected intermediate reading acuity (bUIRA)

    Time frame: 1 year

    bUIRA is obtained using the near vision test of DDART at 60 cm distance.

  3. Binocular uncorrected near reading acuity (bUNRA)

    Time frame: 1 year

    bUNRA is obtained using the near vision test of DDART at 40 cm distance.

  4. Binocular uncorrected intermediate critical print size (bUICPS)

    Time frame: 1 year

    bUICPS is obtained using the near vision test of DDART at 60 cm distance.

  5. Binocular uncorrected near critical print size (bUNCPS)

    Time frame: 1 year

    bUNCPS is obtained using the near vision test of DDART at 40 cm distance.

Secondary outcomes

  1. Dysphotopsia symptoms

    Time frame: 1 year

    Dysphotopsia is evaluated with two direct 4-scale, Likert-type questions (Always, Most of the times, Sometimes, Never) assessing subjective appearance of glare and halos.

  2. Contrast sensitivity

    Time frame: 1 year

    Contrast sensitivity is evaluated with the Pelli-Robson test.

  3. Spectacle independence

    Time frame: 1 year

    Spectacle dependence is assessed for both distant and near vision by two direct 4-scale Likert-type questions (Always, Most of the times, Sometimes, Never).

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

    Time frame: 1 year

    Subjective satisfaction rates are assessed using the prevalent VF-14 questionnaire. 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

Comparative Study of Premium Monovision and Bilateral Implantation of Trifocal Diffractive Intraocular Lenses

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 9, 2022
Registry last updated
Jun 18, 2023

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.