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

• Sponsor: Democritus University of Thrace (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05494177
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia; Refractive Errors; Cataract	Diagnostic Test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS; Diagnostic Test: Contrast sensitivity

Detailed Description

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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Comparative Study of Premium Monovision and Bilateral Implantation of Trifocal Diffractive Intraocular Lenses
• Actual Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Premium monovision Patients will undergo to implantation of an extended depth of field intraocular lens in the dominant eye and a trifocal diffractive intraocular lens in the non-dominant eye.	Diagnostic Test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS; 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).; Diagnostic Test: Contrast sensitivity; Contrast sensitivity is assessed with the Pelli-Robson test.
Bilateral trifocal diffractive implantation Patients will undergo to bilateral implantation of trifocal diffractive lenses.	Diagnostic Test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS; 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).; Diagnostic Test: Contrast sensitivity; Contrast sensitivity is assessed with the Pelli-Robson test.

Outcome Measures

Primary Outcome Measures

1. Binocular uncorrected distant visual acuity (bUDVA) [1 year]

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

2. Binocular uncorrected intermediate reading acuity (bUIRA) [1 year]

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

3. Binocular uncorrected near reading acuity (bUNRA) [1 year]

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

4. Binocular uncorrected intermediate critical print size (bUICPS) [1 year]

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

5. Binocular uncorrected near critical print size (bUNCPS) [1 year]

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

Secondary Outcome Measures

1. Dysphotopsia symptoms [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 [1 year]

   Contrast sensitivity is evaluated with the Pelli-Robson test.

3. Spectacle independence [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology, University Hospital of Alexandroupolis	Alexandroupolis	Evros	Greece	68100

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: NCT05494177
• Other Study ID Numbers: ES13/Th7/07-07-2022
• First Posted: Aug 9, 2022
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• 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: pseudophakic presbyopic correction; premium monovision; trifocal diffractive intraocular lenses; extended depth of field intraocular lenses
• Additional relevant MeSH terms: Cataract; Presbyopia; Refractive Errors

Study Results

No Results Posted as of Aug 9, 2022