Anterior Chamber Depth Variability Between Two Lenses With Different Materials

Anterior Chamber Depth (ACD) Variability Between the Clareon and Acrysof IOL: a Randomised Trial

Compare the change of the Anterior chamber depth (ACD) variability between the Clareon and the AcrySof Intraocular lens (IOL) after implantation over 6 months.

Study Overview

• Status: Unknown
• Conditions: Cataract
• Intervention / Treatment: Procedure: Cataract surgery

Detailed Description

Patients undergoing cataract surgery are often otherwise healthy and active with their only restriction being reduced visual quality. Within the past few years, intraocular lenses (IOLs) have been improved to fulfill the needs of these patients. Nowadays efforts are aiming for the enhancement of the patient vision and his subjective satisfaction postoperative.

One of the best ways to accomplish this is to have a perfect intraocular lens (IOL) power calculation. However, the best calculation can't help if the implanted intraocular lens (IOL) changes its position after implantation.

It should be considered that an anterior chamber depth (ACD) shift, decentration, tilt or rotation of an IOL could result in a reduction in visual quality. For an aspherical IOL, for instance, it is essential not to be decentrated and tilted more than 0.4 mm 2 (0.8 mm 3) and 7° 2 (10° 3), respectively. Otherwise it will be outperformed by a spherical IOL. The estimation of the post-operative intraocular lens (IOL) position and therefore the estimated anterior chamber depth (ACD) is presently the main source of error (35% 4 to 42% 5) in IOL power calculation and therefore for the refractive outcome of the patients after cataract surgery. Presently the pre-operatively measured ACD is taken into account for several IOL power calculation formulas, such as the Haigis formula, the Holladay II formula and the Olsen formula.

To manage a better outcome an IOL with less postoperative influence of the anterior chamber depth (ACD) is very important. To accomplish a smaller deviation after the operation of the anterior chamber depth (ACD) the haptic and the material of the lens is very important. The change of the anterior chamber depth (ACD) after cataract surgery can be easily measured by instruments like the IOL-Master 700, AC-Master and Lenstar. It must be considered that every person is different and that change of the anterior chamber depth (ACD) in different eyes can cause high measurement errors. The changes in two eyes of the same patient help to minimize the error. These can help to achieve a better outcome for future patients.

The hydrophobic acrylate of the Acrysof IOL has been modified to the new material in the Clareon IOL. This study will evaluate whether the new Clareon has non-inferior axial stability to the Acrysof.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Recruiting
    • Vienna Institute for Research in Ocular Surgery (VIROS)
    • Contact: Julius Hienert, MD; Phone Number: 01/ 91021/ 57564; Email: office@viros.at
    • Contact: Manuel Ruiß, MSc.; Phone Number: 01/ 91021/ 57564; Email: office@viros.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age-related cataract in both eyes
• Scheduled for bilateral cataract surgery
• Age 21 and older
• Written informed consent prior to recruitment
• Visual Acuity > 0.05

Exclusion Criteria:

• Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
• Any ophthalmic abnormality that could compromise visual function or the measurements
• Presence of potential zonular weakness such as pseudoexfoliation Syndrome, history of ocular trauma, previous ocular surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monofocal IOL; Patients will be implanted with two different monofocal lenses (Clareon and AcrySof) during cataract surgery	Procedure: Cataract surgery; During cataract surgery the patient is implanted with the monofocal IOL Clareon in one eye and the monofocal IOL AcrySof in the contralateral eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior chamber depth (ACD)	The change in anterior chamber depth (ACD) before and after cataract surgery will be measured using the IOL Master 700 and compared between the two different IOLs.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance visual acuity	Uncorrected and corrected distance visual acuity will be determined using ETDRS-charts in a distance of 4 metres and differences in refraction will be compared between the two IOLs.	12 months

Collaborators and Investigators

• Sponsor: Prim. Prof. Dr. Oliver Findl, MBA

Publications and helpful links

General Publications

• Ullrich M, Ruiss M, Hienert J, Pilwachs C, Fisus AD, Georgiev S, Hirnschall N, Findl O. Anterior chamber depth variability between 2 hydrophobic acrylic 1-piece intraocular lenses: randomized trial. J Cataract Refract Surg. 2021 Nov 1;47(11):1460-1465. doi: 10.1097/j.jcrs.0000000000000668.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Cataract surgery; Cataract; Intraocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Clareon

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No