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Safety and efficacy of hypertonic saline solution (5%) versus placebo in the treatment of postoperative corneal edema after uneventful phacoemulsification: a randomized double-blind study

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Abstract

Purpose

To evaluate safety and efficacy of hypertonic saline solution administration after uneventful cataract surgery.

Design

Prospective double-blind randomized study

Methods

In total, 183 eyes of 183 patients undergoing phacoemulsification were randomly allocated into two equal groups. Treatment group (TG) subjects received single-dose hypertonic (NaCl 5%) solution 4 times daily for 14 days, while placebo group (PG) received single dose of normal saline solution (0.9%) at the same frequency in addition to ordinary postoperative treatment. All patients underwent assessment of central corneal thickness (CCT), endothelial cell density (ECD), best-corrected visual acuity (BCVA), clinical staging of postoperative corneal edema and questionnaire regarding the procedure success and impact on patient’s life. Measurements were taken at baseline and 1, 4, 9 and 30 days following surgery.

Results

CCT increased by 134.67 ± 94.51 μm (25.1 ± 19.4%) on postoperative day 1, without any difference between study groups (p = 0.58). Corneal edema showed a significant recession in TG compared to PG on day 4, in terms of both pachymetry (10.73% vs 7.39%, p = 0.004), BCVA (BCVATG = 0.64 ± 0.24 [logMARTG = 0.25 ± 0.3], BCVAPG = 0.56 ± 0.23 [logMARPG = 0.33 ± 0.3], p = 0.04) and clinical staging (p = 0.02). Similar results were recorded on postoperative day 9 in subjects demonstrating marked corneal edema on the first postoperative day. Endothelial cell loss showed no statistically significant difference between study groups (p = 0.48). No adverse events were recorded in relation to treatment. More patients in the TG (92.4% vs 57.1% in the PG) reported a subjectively clear vision 1 week postoperatively (p = 0.04).

Conclusion

The use of 5% hypertonic saline solution is found to be a safe and effective adjunct in the management of postoperative corneal edema after uneventful phacoemulsification, achieving rapid corneal clearance and expediting a good visual outcome, especially in cases with marked postoperative edema.

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Funding

No financial grants or funds received in support of the study.

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Authors and Affiliations

  1. Department of Ophthalmology, Faculty of Medical School, Papageorgiou General Hospital, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece

    Argyrios Tzamalis, Maria Dermenoudi, Asterios Diafas, Eirini Oustoglou, Artemis Matsou, Nikolaos Ziakas & Ioannis Tsinopoulos

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  1. Argyrios Tzamalis
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  2. Maria Dermenoudi
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  3. Asterios Diafas
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  4. Eirini Oustoglou
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  5. Artemis Matsou
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  6. Nikolaos Ziakas
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  7. Ioannis Tsinopoulos
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Correspondence to Argyrios Tzamalis.

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Conflict of interest

No proprietary interest in any of the products mentioned in the study. All authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.

Informed consent

Informed consent was obtained from all individual participants included in the study. The study was performed with informed consent and following all the guidelines for experimental investigations required by the Institutional Review Board of Ethics Committee of which all authors are affiliated.

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The contents of this manuscript have not been copyrighted or published previously and will not be submitted elsewhere while consideration for publication. There are no directly related manuscripts or abstracts, published or unpublished, by any authors of this paper.

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Asterios Diafas and Argyrios Tzamalis contributed equally to this work.

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Tzamalis, A., Dermenoudi, M., Diafas, A. et al. Safety and efficacy of hypertonic saline solution (5%) versus placebo in the treatment of postoperative corneal edema after uneventful phacoemulsification: a randomized double-blind study. Int Ophthalmol 40, 2139–2150 (2020). https://doi.org/10.1007/s10792-020-01395-4

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  • DOI: https://doi.org/10.1007/s10792-020-01395-4

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