Visual Acuity After Using A New Monofocal Intraocular Lens Compared To Standard Monofocal Lens

Lenses, Intraocular Clinical Trial

Official title:

Distance And Intermediate Visual Acuity After Phacoemulsification Using A New Generation Monofocal Intraocular Lens Compared To Standard Monofocal Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05430295
• Other study ID #: MS-239-2021
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: September 2022
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. Twenty patients (20) were enrolled in this study 10 patients in each group. It was designed for comparison of uncorrected and best corrected distance and intermediate vision in patients whom implanted with monofocal Tecnis Eyhance or Tecnis 1-piece IOLs.

Description:

Purpose To determine the Uncorrected and best-corrected distance, and intermediate visual acuity in a new innovative monofocal intraocular lens compared with standard monofocal lens. Methods This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. 40 eyes of Twenty patients (20) were enrolled in this study, patients who are candidates for cataract extraction by phacoemulsification were included in this study and underwent thorough preoperative examination and post-operative evaluation at 3 months after the 2nd eye operation, of distance, intermediate, near add, contrast sensitivity and incidence of photic phenomena using a printed questionnaire for evaluating this incidence and binocular defocus curves were analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients aged 50-75 years old undergoing cataract surgery.
• Preoperative corneal astigmatism equal to or less than - 1.00 D.
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

• Visual potential of less than 0.63 due to ocular pathologies.
• Corneal astigmatism over -1.00 D cylinder.
• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions).
• Capsule or zonular abnormalities that would affect postoperative centration or tilt of the lens and pseudoexfoliation syndrome.
• Macular degeneration, cystoid macular edema,Diabetic retinopathy, history of uveitis, optic nerve diseases, glaucoma and amblyopia.

Related Conditions & MeSH terms

• Lenses, Intraocular

Intervention

Procedure:
• phacoemulsification
cataract extraction followed by bilateral implantation of Eyhance intraocular lens in 10 patients and bilateral implantation of Tecnis 1 piece IOL in 10 patients
• monofocal intraocular lens implantation
implantation of monofocal intraocular lens in the capsular bag at the end of phacoemulsification surgery

Locations

Country	Name	City	State
Egypt	Kasraliany Hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected and best-corrected distance, and intermediate visual acuity.	Distance visual acuities were examined by ETDRS chart and intermediate and near visual acuity by Jaeger chart at 66 cm and 33 cm respectively.Measured values of the visual acuity were expressed in decimal values and converted to logMAR values.	3 months post operative
Secondary	Contrast sensitivity	Contrast sensitivity was measured using Pelli Robson illuminated chart at 1m	3 months post operative