Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460389
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-11
Brief Title:
Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance
Sponsor:
Democritus University of Thrace
Organization:
Democritus University of Thrace
Study Overview
Official Title:
Comparison of Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to compare the postoperative visual acuity curves of patients that underwent one of the following surgical procedures Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance
Detailed Description:
This is a prospective comparative study of 60 patients diagnosed with grade 2 cataracts according to LOCS III that underwent one of the following surgical procedures Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance
In these patients a comparison of postoperative visual acuity curves of both groups will be conducted Visual acuity curves will be designed using the validated digital optotype Democritus Digital Acuity Reading Test DDART Assessment of visual acuity will be performed at 9 different distances 25 28 33 40 50 60 100 200 300 cm Overall visual acuity curves and the area under the curve will be formed through the application as the primary means of evaluating visual capacity Additionally the degree of subjective satisfaction of the patient will be evaluated through an interview NEI-VFQ 25 All examinations will be conducted according to standard clinical practice
In these patients a comparison of postoperative visual acuity curves of both groups will be conducted Visual acuity curves will be designed using the validated digital optotype Democritus Digital Acuity Reading Test DDART Assessment of visual acuity will be performed at 9 different distances 25 28 33 40 50 60 100 200 300 cm Overall visual acuity curves and the area under the curve will be formed through the application as the primary means of evaluating visual capacity Additionally the degree of subjective satisfaction of the patient will be evaluated through an interview NEI-VFQ 25 All examinations will be conducted according to standard clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None