Cataract Clinical Trial
Official title:
Premium Monovision Versus Bilateral Myopic Monovision, Hybrid Monovision and Bilateral Trifocal Implantation. A Comparative Study.
Verified date | November 2020 |
Source | Democritus University of Thrace |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Greece | Department of Ophthalmology, University Hospital of Alexandroupolis | Alexandroupolis | Evros |
Lead Sponsor | Collaborator |
---|---|
Democritus University of Thrace |
Greece,
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
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 |
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