Evidence map›Paper›PMID 40165267›Full record

ArticleEye and vision (London, England)2025

Randomized controlled trial on corneal denervation, neuroinflammation and ocular surface in corneal lenticule extraction for advanced refractive correction (CLEAR) and small incision lenticule extraction (SMILE).

Mingyi Yu, Chang Liu, Isabelle Xin Yu Lee, Victor Wei-Tse Hsu, Regina Kay Ting Wong, Ansa Anam, Rong Lim, Jodhbir S Mehta, Yu-Chi Liu

Registry-linked trialAbstract read
In one paragraph

Article in Eye and vision (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06774651 (Comparison of Femto LDV Z8 Corneal Lenticule Extraction for Advanced Refractive Correction), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT06774651 recruitingnot on this map

Comparison of Femto LDV Z8 Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) and Visumax Small Incision Lenticule Extraction (SMILE)

TypeobservationalSponsorSingapore Eye Research InstituteRan2023 to 2025Enrolled65ConditionsMyopiaArmsProcedure: Corneal lenticule extraction for advanced refractive correction (CLEAR), Procedure: Small Incision Lenticule Extraction (SMILE)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

9 authors.

Mingyi YuTissue Engineering and Cell Therapy Group, Singapore Eye Research Institute, The Academia, 20 College Road, Discovery Tower, Singapore, S169856, Singapore.
Chang LiuTissue Engineering and Cell Therapy Group, Singapore Eye Research Institute, The Academia, 20 College Road, Discovery Tower, Singapore, S169856, Singapore.
Isabelle Xin Yu LeeTissue Engineering and Cell Therapy Group, Singapore Eye Research Institute, The Academia, 20 College Road, Discovery Tower, Singapore, S169856, Singapore.
Victor Wei-Tse HsuTissue Engineering and Cell Therapy Group, Singapore Eye Research Institute, The Academia, 20 College Road, Discovery Tower, Singapore, S169856, Singapore.
Regina Kay Ting WongTissue Engineering and Cell Therapy Group, Singapore Eye Research Institute, The Academia, 20 College Road, Discovery Tower, Singapore, S169856, Singapore.
Ansa AnamDepartment of Ophthalmology, MTI Khyber Teaching Hospital, Peshawar, Pakistan.
Rong LimLee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.
Jodhbir S MehtaTissue Engineering and Cell Therapy Group, Singapore Eye Research Institute, The Academia, 20 College Road, Discovery Tower, Singapore, S169856, Singapore.
Yu-Chi LiuTissue Engineering and Cell Therapy Group, Singapore Eye Research Institute, The Academia, 20 College Road, Discovery Tower, Singapore, S169856, Singapore. liuchiy@gmail.com.ORCID http://orcid.org/0000-0001-5408-0382

Funding

Singapore National Medical Research Council MOH-CSAINV21jun-0001
6 · The paper itself

Abstract

backgroundTo investigate and compare the corneal denervation, tear neuromediators, and ocular surface changes following corneal lenticule extraction for advanced refractive correction (CLEAR) versus small incision lenticule extraction (SMILE).

methodsIn this randomized clinical trial, 19 patients were randomized to undergo CLEAR in one eye and SMILE in the other eye. Ocular surface assessments, in vivo confocal microscopy for seven corneal nerve parameters, four corneal dendritic cell parameters, three corneal epithelial parameters, and tear neuromediator analysis were performed preoperatively and 1, 3, 6 and 12 months postoperatively.

resultsThere were no significant differences in all ocular surface assessments between CLEAR and SMILE throughout postoperative 1 year. CLEAR and SMILE led to significant and comparable reductions of corneal nerve fiber density (CNFD), nerve branch density, total branch density, nerve fiber length, area, and fiber fractal dimension, which did not restore even at 1 year. The reduction in CNFD was significantly correlated with the corrected spherical equivalent in both surgical types. Although post-SMILE eyes had significantly higher nerve growth factor concentrations at 1 month, there was no significant difference in substance P and calcitonin gene-related peptide (CGRP) concentrations between SMILE and CLEAR.

conclusionsCLEAR and SMILE had comparable effects on ocular surface, corneal denervation and postoperative neuroinflammation. Corneal nerve metrics did not restore even at 1 year for both procedures. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT06774651, registration on 14 January 2025, https://clinicaltrials.gov/study/NCT06774651 .

Indexed as

Corneal denervation, NeuromediatorCorneal lenticule extraction for advanced refractive correction (CLEAR)NeuroinflammationOcular surfaceSmall incision lenticule extraction (SMILE)

Identifiers

PMID40165267
PMCPMC11959778

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.