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The aim is to evaluate the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx) and small-incision lenticule extraction (SMILE) procedures.
The use of femtosecond (FS) laser has become one of the most significant technological advancements in refractive surgery. A breakthrough FS laser-assisted myopic and myopic astigmatic correction procedure can now be performed using a prototype femtosecond system. This first all-in-one FS-laser system was designed to perform the refractive lenticule extraction (ReLEx) procedures, femtosecond lenticule extraction (FLEx) and small-incision lenticule extraction (SMILE). In FLEx, a corneal flap is created by the FS laser (similar to LASIK) and lifted, allowing lenticule removal. For SMILE, a truly without flap procedure, only a small-2-4mm- incision is made, through which the lenticule is removed.
Ocular surface disruption during corneal refractive surgery is commonly considered to be closely related to the development of dry eye. Multiple etiologies contribute to this ocular surface disruption, including the flap creation and stromal ablation involved in previous refractive surgery techniques. Corneal nerve damage has been considered the main cause of dry eye, due to disrupted afferent sensory nerves, reduced blink reflex, and increased tear evaporation leading to tear film instability. In addition, postoperative inflammatory mediator fluctuations are also a key factor related to ocular surface damage. Extensive research has described the effects of cytokines, chemokines and growth factors in modulating corneal wound healing, cell migration, and apoptosis on the ocular surface after refractive surgery.
For both FLEx and SMILE, stromal ablation has been replaced by refractive lenticule removal. In terms of corneal flap formation, FLEx still requires an epithelial-stromal flap, while SMILE employs only a small incision to extract the lenticule. Hence, the investigators hypothesize that SMILE will have less effect on patients' ocular surface markers and inflammatory mediators, compared to FLEx. In support of this hypothesis, previous studies have reported that more damage to the sub-basal nerve plexus of the cornea and more changes in ocular surface evaluations were found after FLEx than after SMILE. In this study, the investigators have focused on postoperative changes to tear inflammatory mediators and the relationship of FLEx and SMILE to dry eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lenticule extraction | Experimental | The patients in this group chose to receive the lenticule extraction surgery. |
|
| small-incision lenticule extraction | Experimental | The patients in this group chose to receive the small-incision lenticule extraction surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lenticule extraction | Procedure | Four femtosecond incisions were created in succession: the posterior surface of the refractive lenticule (spiral in), the lenticule border, the anterior surface of the refractive lenticule (spiral out), and the corneal flap in the superior region. After the suction was released, the flap was opened using a thin, blunt spatula and the free refractive lenticule was subsequently grasped with a forceps and extracted, after which the flap was repositioned carefully |
| Measure | Description | Time Frame |
|---|---|---|
| scale of Schirmer I test | up to 1month after surgery | |
| scale of corneal fluorescein staining | up to 1month after surgery | |
| scale of noninvasive tear breakup time | up to 1month after surgery | |
| questionnaire of ocular surface disease index | up to 1month after surgery | |
| scale of central corneal sensitivity | up to 1month after surgery | |
| scale of tear meniscus height | up to 1month after surgery | |
| concentration of Interleukin-1α | up to 1month after surgery | |
| concentration of tumor necrosis factor-α | up to 1month after surgery | |
| concentration of nerve growth factor | up to 1month after surgery | |
| concentration of interferon-γ | up to 1month after surgery | |
| concentration of transforming growth factor-β1 | up to 1month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Inflammatory Mediators and Ocular Surface Changes | up to 1month after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xingwu Zhong, MD PhD | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26937680 | Derived | Zhang C, Ding H, He M, Liu L, Liu L, Li G, Niu B, Zhong X. Comparison of Early Changes in Ocular Surface and Inflammatory Mediators between Femtosecond Lenticule Extraction and Small-Incision Lenticule Extraction. PLoS One. 2016 Mar 3;11(3):e0149503. doi: 10.1371/journal.pone.0149503. eCollection 2016. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014031 | Tobramycin |
| D003907 | Dexamethasone |
| D000078162 | Tobramycin, Dexamethasone Drug Combination |
| C022030 | methylacetylene |
| D064704 | Levofloxacin |
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 |
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|
|
| small-incision lenticule extraction | Procedure | Four femtosecond incisions were created in succession: the posterior surface of the refractive lenticule (spiral in), the lenticule border, the anterior surface of the refractive lenticule (spiral out), make a small incision |
|
|
| concentration of matrix metalloproteinase-9 | up to 1month after surgery |
| Carbohydrates |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |