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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05494177
• Other study ID #: ES13/Th7/07-07-2022
• Status: Completed
• Start date: August 1, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: August 2022
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Presbyopia
• Refractive Errors

Intervention

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).
• Contrast sensitivity
Contrast sensitivity is assessed with the Pelli-Robson test.

Locations

Country	Name	City	State
Greece	Department of Ophthalmology, University Hospital of Alexandroupolis	Alexandroupolis	Evros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular uncorrected distant visual acuity (bUDVA)	bUDVA is obtained using the distance vision test of DDART at four meters distance.	1 year
Primary	Binocular uncorrected intermediate reading acuity (bUIRA)	bUIRA is obtained using the near vision test of DDART at 60 cm distance.	1 year
Primary	Binocular uncorrected near reading acuity (bUNRA)	bUNRA is obtained using the near vision test of DDART at 40 cm distance.	1 year
Primary	Binocular uncorrected intermediate critical print size (bUICPS)	bUICPS is obtained using the near vision test of DDART at 60 cm distance.	1 year
Primary	Binocular uncorrected near critical print size (bUNCPS)	bUNCPS is obtained using the near vision test of DDART at 40 cm distance.	1 year
Secondary	Dysphotopsia symptoms	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.	1 year
Secondary	Contrast sensitivity	Contrast sensitivity is evaluated with the Pelli-Robson test.	1 year
Secondary	Spectacle independence	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).	1 year
Secondary	Subjective satisfaction using Visual Function Index (VF-14) (total score, VF14-Near Vision (NV) score & VF14-Distance Vision (DV) score)	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.	1 year