An interventional study of IFIOL and SFIOL in Cataract, sponsored by Vienna Institute for Research in Ocular Surgery. Enrolling by invitation at 1 site in Austria. Open to participants aged 21 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Vienna Institute for Research in Ocular Surgery · Not applicable, Interventional, and Basic science
Assessment and differences in the centration, tilt and wobble of two secondary IOLs without capsular support.
Acquired or congenital weakness of the zonules, either as part of a pseudoexfoliation syndrome (PEX), high myopia, past ocular trauma, post vitreoretinal surgery, and recurrent uveitis are the most common reasons for implantation of a secondary intraocular lenses (IOL) after cataract surgery. There are several techniques available to implant a secondary IOL in eyes with inadequate capsular support. Some of the most common techniques are the placement of a chamber angle-supported anterior chamber IOL (ACIOL), an iris-fixated IOL (IFIOL) and several different possibilities of scleral fixation of the IOL (SFIOL).
While those methods have all been found to show high safety and efficiency, there are certain procedure-specific limitations. One approach to sutureless implantation of a SFIOL is the "double needle flanged technique" described by Yamane et al. When using this technique, there is no need for extensive scleral incisions or distinct scleral manipulation, however, it may be challenging for the surgeon and may lead to complications such as "iris-optic-capture".
Past studies found no significant difference of postoperative best corrected visual acuity or rate of complications when comparing the three mentioned techniques, therefore, up to now choice of implantation and fixation technique lies with the surgeon's preferences and abilities. However, all three techniques have their drawbacks.
Hence, the aim of this study is to assess the centration, tilt, and wobble of secondary IOLs (comparing an IFIOL and a SFIOL) without capsular support.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 82 is close to the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Vienna Institute for Research in Ocular Surgery is the lead sponsor of 65 studies on the registry; 8 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with an implanted IFIOL
Device: IFIOL
Patients with an implanted SFIOL
Device: SFIOL
Implanted IFIOL
Implanted SFIOL
Centration of the IOL
Centration of the IOL will be measured in mm using a Purkinjemeter
Time frame: 24 months
Tilt of the IOL
Tilt of the IOL will be measured in degrees using a Purkinjemeter
Time frame: 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2022 (actual). Primary completion is estimated for Dec 2025, 36 months after the start.
Of 300 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 36 months is above that.
Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
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Vienna Institute for Research in Ocular Surgery