Postoperative Total Wavefront Pattern Between Two Types of Intraocular Lenses Implanted in Cataract Surgery

NCT04701255 | Unknown FDA Device

• 1 other identifier: 336-2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

With the advancement of cataract eye surgery and wavefront sensors, the previously unquantifiable refractive measurements have been identified and the high order aberrations have shown their effect on high resolution imaging. In the human phakic eye, the shape of the normal cornea induces average positive spherical aberration and remains unchanged over time, whereas the crystalline lens has a negative spherical aberration. As a result, overall spherical aberration in the young eye is low. However, the compensation slowly decreases with the aging lens and is fully lost after cataract extraction and implantation of a standard intraocular lens. Optical studies showed that conventional biconvex spherical intraocular lenses add their intrinsic positive spherical aberration to the positive spherical aberration of the cornea resulting in image imperfection and blur. As a useful side effect, this also increases the depth of focus -often referred to as pseudo-accommodation. New Aspheric intraocular lenses designs currently in use impart negative spherical aberration, about 0.17 to 0.20 microns of negative spherical aberration. This added negative spherical aberration partially corrects the average amount of corneal positive spherical aberration \& compensate for its effect. Our study will include (FocusForce foldable aspheric intraocular lens, Bausch \& Lomb, New Jersey, USA) as an example of this type of negative spherical aberration intraocular lenses. In order to improve retinal image quality without compromising depth of field, or introducing other aberrations, aberration-free aspheric intraocular lenses were developed with no inherent spherical aberration. The other intraocular lens targeted in our study (Akreos AO Microincision lens, Bausch \& Lomb, New Jersey, USA) is an example of this type of IOLs.

Conditions

Cataract

Keywords

aberration-free; negative spherical aberration; phacoemulsification; intraocular lens; wavefront

Outcome Measures

Primary Outcomes (1)

• Corneal, Ocular, and Internal spherical aberrations

  assessment of ocular, corneal \& internal wavefront by aberrometer \& corneal tomography

  1 month postoperative

Secondary Outcomes (2)

• corneal wavefront changes

  1 month postoperative

• near vision addition

  1 month postoperative

Study Arms (2)

aberration-free IOL

EXPERIMENTAL

20 human eyes with aberration-free intraocular lens Implantation after phacoemulsification cataract surgery

Procedure: phacoemulsification with intraocular lens implantation; Device: ocular aberrometer assesment

negative spherical aberration IOL

ACTIVE COMPARATOR

20 human eyes with negative spherical aberration intraocular lens Implantation after phacoemulsification cataract surgery

Procedure: phacoemulsification with intraocular lens implantation; Device: ocular aberrometer assesment

Interventions

phacoemulsification with intraocular lens implantation PROCEDURE

treatment of cataract by phacoemulsification procedure and implantation of different types of IOLs.

aberration-free IOL; negative spherical aberration IOL

ocular aberrometer assesment DEVICE

evaluate total ocular wavefront, corneal wavefront \& internal wavefront (High order aberrations ) post operative by corneal tomography and aberrometer

aberration-free IOL; negative spherical aberration IOL

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with written informed consent, between the age of 21 -75 years who will undergo phacoemulsification procedure with intraocular lens implantation of one of the targeted lenses in the study

You may not qualify if:

• Previous corneal intervention or refractive surgery.
• Persistent Corneal edema (epithelial or stromal).
• Co-existing corneal pathology.
• Ocular surface disease \& Dry eye syndrome.
• Posterior capsular opacity .
• Anterior capsular contraction (phimosis).
• Ocular inflammation.
• Co-existing Vitreoretinal diseases.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

facultyof medicine, Cairo university

Cairo, 12563, Egypt

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Phacoemulsification; Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Aya G Ibrahim, MBBCh

  Dar El Oyoun ophthalmology hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed H Hosny, professor

CONTACT

00201000007675; hosnylasik@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident of ophthalmology

Model Details: 40 human eyes undergoing phacoemulsification with intraocular lens implantation

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: November 9, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)