An interventional study of Cataract surgery in Cataract, sponsored by Prim. Prof. Dr. Oliver Findl, MBA. Status unknown at 1 site in Austria. Open to participants aged 21 Years to 105 Years. Per ClinicalTrials.gov, last updated 2019-04-19.
Sponsored by Prim. Prof. Dr. Oliver Findl, MBA · Not applicable, Interventional, and Treatment
Compare the change of the Anterior chamber depth (ACD) variability between the Clareon and the AcrySof Intraocular lens (IOL) after implantation over 6 months.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Prim. Prof. Dr. Oliver Findl, MBA is the lead sponsor of 38 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
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.
Time frame: 12 months
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.
Time frame: 12 months
Plan to share: Undecided
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Prim. Prof. Dr. Oliver Findl, MBA