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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04618380
• Other study ID #: ES13/Th9/22-10-2020
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: November 1, 2020

Study information

• Verified date: November 2020
• 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 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 1, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Presbyopia
• Refractive Errors

Intervention

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.

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, 

References & Publications (1)

Labiris G, Panagiotopoulou EK, Chatzimichael E, Tzinava M, Mataftsi A, Delibasis K. Introduction of a digital near-vision reading test for normal and low vision adults: development and validation. Eye Vis (Lond). 2020 Oct 22;7:51. doi: 10.1186/s40662-020- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular uncorrected distant visual acuity [bUD-VA]	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.	through study completion, an average of 2.5years
Primary	Binocular uncorrected intermediate reading acuity (at 60cm) [bUI-RA)]	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.	through study completion, an average of 2.5years
Primary	binocular uncorrected near reading acuity (at 40cm) [bUN-RA]	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.	through study completion, an average of 2.5years
Primary	binocular uncorrected intermediate critical print size (at 60cm) [bUI-CPS]	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.	through study completion, an average of 2.5years
Primary	binocular uncorrected near critical print size (at 40cm )[bUN-CPS]	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.	through study completion, an average of 2.5years
Secondary	Dysphotopsia symptoms	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.	through study completion, an average of 2.5years
Secondary	Contrast sensitivity	Contrast sensitivity is evaluated with the Pelli-Robson test. This parameter is obtained six months following the operation of the second eye.	through study completion, an average of 2.5years
Secondary	Spectacle independence	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.	through study completion, an average of 2.5years
Secondary	Subjective satisfaction using Visual Function Index (VF-14 instrument) (total score, VF14-NV score & VF14-DV score)	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.	through study completion, an average of 2.5years