Evidence map›Paper›PMID 40013529›Full record

Trial reportActa ophthalmologica2025

Long-term results after sutureless intrascleral fixation of the Carlevale intraocular lens: Changes in scleral pocket thickness over time.

Markus Schranz, Ioanna Dimakopoulou, Marcus Lisy, Victor Danzinger, Daniel Schartmüller, Claudette Abela-Formanek

Abstract readClinical Trial
In one paragraph

Trial report in Acta ophthalmologica, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Markus SchranzDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.ORCID https://orcid.org/0000-0002-2630-1368
Ioanna DimakopoulouDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.ORCID https://orcid.org/0000-0002-7561-3093
Marcus LisyDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
Victor DanzingerDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.ORCID https://orcid.org/0000-0003-1736-0259
Daniel SchartmüllerDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
Claudette Abela-FormanekDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo investigate the long-term effects and dynamic changes in scleral thickness above the T-haptic after sutureless scleral-fixated intraocular lens (sSFIOL) implantation using the FIL-SFF Carlevale lens.

settingSingle-centre, single-surgeon, prospective clinical trial, Department of Ophthalmology, Medical University of Vienna, Austria.

methodsThirty-six eyes of 36 consecutive patients met the inclusion criteria for this post hoc analysis. Visual acuity, tilt and decentration of the IOL, as well as complications, were evaluated alongside imaging of the scleral pockets during multiple time points using the anterior optical coherence tomography (AS-OCT) system Tomey CASIA 2 in the bleb mode. The OCT scan pattern, oriented parallel to the T-shaped haptic of the IOL, facilitated manual analysis of images to measure scleral pocket thickness on both the temporal and nasal haptics. To compensate for distortions and non-perpendicular image acquisition, distal T-haptic thickness was also measured to calculate the relative scleral pocket thickness. For statistical evaluation, a linear mixed model was used, where we corrected for multiple measurements.

resultsThe mean follow-up period was 28 ± 11 months. Measured scleral thickness above the T-haptic exhibited a significant decrease on both temporal and nasal sides, translating to an estimated annual decrease of approximately 0.03 mm (p < 0.001). Postoperatively, best-corrected visual acuity (BCVA) significantly improved from 0.77 ± 0.74 logMAR preoperatively to 0.41 ± 0.60 (p < 0.001). IOL tilt increased slightly from 7.23° ± 3.43° to 7.71° ± 3.70° (p = 0.003), while decentration significantly decreased from 0.41 ± 0.21 to 0.39 ± 0.20 mm (p < 0.001) postoperatively.

conclusionsLong-term evaluation of Carlevale sSFIOL implantation demonstrated a significant improvement in postoperative BCVA. However, we observed a thinning of the scleral pocket thickness, raising questions about its clinical significance and the viability of subconjunctival placement of T-haptics in the long term. Further studies are necessary to evaluate the long-term patency of the scleral pocket.

Indexed as

Lenses, IntraocularLens Implantation, IntraocularScleraSutureless Surgical ProceduresSuture TechniquesVisual AcuityAgedAged, 80 and overFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesProsthesis DesignTime FactorsAphakiaAS‐OCTCarlevaleScleral IOL FixationVitrectomy

Identifiers

PMID40013529
PMCPMC12235683

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.