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Topical Osmoprotectant for the Management of Postrefractive Surgery-Induced Dry Eye Symptoms: A Randomised Controlled Double-Blind Trial.

ABSTRACT: Background:Dry eye disease (DED) is one of the most common complications following refractive surgery. Purpose:Evaluate the efficacy of an osmoprotective eye drop (Optive®) for the management of induced DED in refractive surgery patients. Design:Double-masked randomised controlled trial. Methods:Twenty-two refractive surgery patients oriented to apply FreshTears (FT; n = 13) or Optive (Op; n = 9), topically, QID, for 3 months. Eye exams were performed before surgery (T0) and 1-month (T1) and 3-month (T3) follow-up and consisted of tear film osmolarity, Schirmer 1 test, tear film breakup time (TBUT), fluorescein staining, and ocular surface disease index (OSDI) and patient symptoms questionnaires. Main Outcome Measures:Pain and osmolarity. Results:Pain increased significantly for FT at T3 (p < 0.05). A reduction in osmolarity was observed at T1 and T3 for Op group (p < 0.01) and at T3 for FT group (p < 0.05). TBUT showed a decrease between T0 and T1 for FT (p < 0.05). Schirmer 1 values increased significantly for Op in T1. Conclusions:Op was superior to FT in regard to pain, osmolarity, TBUT, and Schirmer 1. Osmoprotectant solutes, such as L-carnitine, could attenuate inflammation and secondary DED. Osmoprotective lubricants can be effectively applied for the prevention of refractive surgery-related dry eye symptoms and signs.

SUBMITTER: Hazarbassanov RM

PROVIDER: S-EPMC5838485 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Topical Osmoprotectant for the Management of Postrefractive Surgery-Induced Dry Eye Symptoms: A Randomised Controlled Double-Blind Trial.

Hazarbassanov R M RM Queiroz-Hazarbassanov N G T NGT Barros J N JN Gomes J A P JAP

Journal of ophthalmology 20180220

<h4>Background</h4>Dry eye disease (DED) is one of the most common complications following refractive surgery.<h4>Purpose</h4>Evaluate the efficacy of an osmoprotective eye drop (Optive®) for the management of induced DED in refractive surgery patients.<h4>Design</h4>Double-masked randomised controlled trial.<h4>Methods</h4>Twenty-two refractive surgery patients oriented to apply FreshTears (FT; <i>n</i> = 13) or Optive (Op; <i>n</i> = 9), topically, QID, for 3 months. Eye exams were performed b ...[more]

PMID: 29675272

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Project description:Ocular surface squamous neoplasia (OSSN) is an aggressive eye tumour particularly affecting people with HIV in Africa. Primary treatment is surgical excision; however, tumour recurrence is common. We assessed the effect of fluorouracil 1% eye drops after surgery on recurrence.We did this multicentre, randomised, placebo-controlled trial in four centres in Kenya. We enrolled patients with histologically proven OSSN aged at least 18 years. After standard surgical excision, participants were randomly allocated to receive either topical fluorouracil 1% or placebo four times a day for 4 weeks. Randomisation was stratified by surgeon, and participants and trial personnel were masked to assignment. Patients were followed up at 1 month, 3 months, 6 months, and 12 months. The primary outcome was clinical recurrence (supported by histological assessment where available) by 1 year, and analysed by intention to treat. The sample size was recalculated because events were more common than anticipated, and trial enrolment was stopped early. The trial was registered with Pan-African Clinical Trials Registry (PACTR201207000396219).Between August, 2012, and July, 2014, we assigned 49 participants to fluorouracil and 49 to placebo. Four participants were lost to follow-up. Recurrences occurred in five (11%) of 47 patients in the fluorouracil group and 17 (36%) of 47 in the placebo group (odds ratio 0·21, 95% CI 0·07-0·63; p=0·01). Adjusting for passive smoking and antiretroviral therapy had little effect (odds ratio 0·23; 95% CI 0·07-0·75; p=0·02). Adverse effects occurred more commonly in the fluorouracil group, although they were transient and mild. Ocular discomfort occurred in 43 of 49 patients in the fluorouracil group versus 36 of 49 in the placebo group, epiphora occurred in 24 versus five, and eyelid skin inflammation occurred in seven versus none.Topical fluorouracil after surgery substantially reduced recurrence of OSSN, was well-tolerated, and its use recommended.British Council for Prevention of Blindness and the Wellcome Trust.

Dataset Information

Topical Osmoprotectant for the Management of Postrefractive Surgery-Induced Dry Eye Symptoms: A Randomised Controlled Double-Blind Trial.

Publications

Topical Osmoprotectant for the Management of Postrefractive Surgery-Induced Dry Eye Symptoms: A Randomised Controlled Double-Blind Trial.

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