Anterior Chamber Depth Variability Between Two Lenses With Different Materials
Primary Purpose
Cataract
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Cataract surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract, Cataract surgery, Intraocular lens
Eligibility Criteria
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.
Sites / Locations
- Vienna Institute for Research in Ocular Surgery (VIROS)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Monofocal IOL
Arm Description
Patients will be implanted with two different monofocal lenses (Clareon and AcrySof) during cataract surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03751215
First Posted
November 20, 2018
Last Updated
April 17, 2019
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
1. Study Identification
Unique Protocol Identification Number
NCT03751215
Brief Title
Anterior Chamber Depth Variability Between Two Lenses With Different Materials
Official Title
Anterior Chamber Depth (ACD) Variability Between the Clareon and Acrysof IOL: a Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Compare the change of the Anterior chamber depth (ACD) variability between the Clareon and the AcrySof Intraocular lens (IOL) after implantation over 6 months.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Cataract surgery, Intraocular lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Monofocal IOL
Arm Type
Experimental
Arm Description
Patients will be implanted with two different monofocal lenses (Clareon and AcrySof) during cataract surgery
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
During cataract surgery the patient is implanted with the monofocal IOL Clareon in one eye and the monofocal IOL AcrySof in the contralateral eye
Primary Outcome Measure Information:
Title
Anterior chamber depth (ACD)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Distance visual acuity
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julius Hienert, MD
Phone
01/ 91021/ 57564
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Ruiß, MSc.
Phone
01/ 91021/ 57564
Email
office@viros.at
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS)
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julius Hienert, MD
Phone
01/ 91021/ 57564
Email
office@viros.at
First Name & Middle Initial & Last Name & Degree
Manuel Ruiß, MSc.
Phone
01/ 91021/ 57564
Email
office@viros.at
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33929807
Citation
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.
Results Reference
derived
Learn more about this trial
Anterior Chamber Depth Variability Between Two Lenses With Different Materials
We'll reach out to this number within 24 hrs