Dataset Information

Impact of polyethylene glycol 400/propylene glycol/hydroxypropyl-guar and 0.1% sodium hyaluronate on postoperative discomfort following cataract extraction surgery: a comparative study.

ABSTRACT:

Background

Universal postoperative guidelines for cataract extraction surgery are yet to be introduced. Artificial tears are gaining popularity as an additional integral component of the postoperative regime. The primary objective of this study was to explore the impact of two prevalent artificial tear preparations on postoperative discomfort following cataract extraction surgery.

Methods

A total of 180 patients that underwent cataract extraction surgery were randomly divided into three groups according to their postoperative regime: a) Study group 1 (SG1) received a fixed combination of tobramycin and dexamethasone (FCTD) quid for 3 weeks and, additionally polyethylene glycol 400/propylene glycol/hydroxypropyl-guar quid, for 6 weeks, b) Study group 2 (SG2) received FCTD quid for 3 weeks and, additionally 0.1% sodium hyaluronate provided in the COMOD® device quid, for 6 weeks, and, c) Control Group (CG) received only FCTD quid for 3 weeks. The following indexes were evaluated at three postoperative checkpoints: 1) Subjective discomfort index (SDI) derived from four direct 10-scale Likert-type questions that were addressed to the patient and pertained to: a) foreign body sensation (FBS), b) blinking discomfort (BD), c) stinging sensation (SS), d) tearing sensation (TS), 2) Tear break-up time (TBUT), 3) Central corneal thickness (CCT) and, 4) Central Corneal Sensitivity (CCS).

Results

Both groups showed increased CCT values at the first examination point and reduced CCS values at all examination points. Furthermore, both SGs had better TBUT times at all examination points compared to CG (CG: 8.86?±?1.08, SG1: 9.59?±?1.45, CG2: 9.45?±?1.33, p?st week of examination, while SDI values were better until the 3^rd week and only borderline better at 6^th week. Lastly, no significant differences were detected between SGs, regarding all parameters, at all examination points.

Conclusion

Polyethylene glycol 400/propylene glycol/hydroxypropyl-guar and 0.1% sodium hyaluronate provided in the COMOD® device seem to be equally efficient in alleviating OSD symptoms following cataract extraction surgery and any of them should be routinely added to the postoperative regime.

Trial registration

ClinicalTrials.gov Identifier: https://clinicaltrials.gov/ct2/show/NCT02558218NCT02558218.

SUBMITTER: Labiris G

PROVIDER: S-EPMC5424421 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Publications

Impact of polyethylene glycol 400/propylene glycol/hydroxypropyl-guar and 0.1% sodium hyaluronate on postoperative discomfort following cataract extraction surgery: a comparative study.

Labiris Georgios G Ntonti Panagiota P Sideroudi Haris H Kozobolis Vassilios V

Eye and vision (London, England) 20170510

<h4>Background</h4>Universal postoperative guidelines for cataract extraction surgery are yet to be introduced. Artificial tears are gaining popularity as an additional integral component of the postoperative regime. The primary objective of this study was to explore the impact of two prevalent artificial tear preparations on postoperative discomfort following cataract extraction surgery.<h4>Methods</h4>A total of 180 patients that underwent cataract extraction surgery were randomly divided into ...[more]

PMID: 28497070

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Project description:BackgroundRecent artificial tear preparations have provided 0.2% concentration of sodium hyaluronate. However, no published data exist on their potential superiority against 0.1% in alleviating dry-eye-disease symptoms in cataract extraction surgery.MethodsA total of 180 patients that underwent cataract extraction surgery were randomly divided into 2 groups according to their postoperative regime: Study group (SG) received fixed combination of tobramycin and dexamethasone (FCTD) quid for 3 weeks, and additionally 0.2% sodium hyaluronate provided in the COMOD® device quid for 6 weeks. Control group (CG) received fixed combination of tobramycin and dexamethasone (FCTD) quid for 3 weeks, and additionally 0.1% sodium hyaluronate provided in the COMOD® device quid for 6 weeks. The following indexes were evaluated at 3 postoperative checkpoints: 1) Surface discomfort index (SDI) which was derived by four direct 10-scale Likert-type questions that were addressed to the patient and pertained to: a) foreign body sensation (FBS), b) blinking discomfort (BD), c) stinging sensation (SS), d) tearing sensation (TS), 2) Tear break-up time (TBUT), 3) Schirmer's test, 4) Central corneal thickness (CCT), and 4) Central Corneal Sensitivity (CCS).ResultsBoth groups showed reduced CCS values at all postoperative examination points; however, SG participants had significantly better CCS (all p < 0.05). SG had better TBUT than CG at the 3rd (p = 0.03) and 6th examination points (p = 0.04). Moreover, SG had better SDI scores at the 3rd (SDI = 9.26 ± 0.55) and 6th weeks (SDI = 9.47 ± 0.48) vs. CG participants (p = 0.03 and p < 0.01, respectively).ConclusionThe increased 0.2% sodium hyaluronate concentration in the artificial tears provided in the COMOD® device seems to address dry-eye-disease symptoms better in patients who underwent phacoemulsification surgery than the 0.1% concentration.Trial registrationClinicalTrials.gov Identifier: NCT03705949 Oct 15, 2018, retrospectively registered.

Project description:IntroductionThe study aimed to evaluate multi-symptom relief of dry eye manifestations with the use of propylene glycol-hydroxypropyl-guar (PG-HPG) nanoemulsion lubricant eye drops, among subjects with dry eye disease (DED).MethodsThis was a post-marketing, prospective, single-arm study conducted in the USA. Subjects aged ≥ 18 years, with tear breakup time (TBUT) ≤ 10 s for both eyes, dry eye questionnaire-5 (DEQ-5) "watery eyes" symptom score 1-4, symptoms of burning/stinging, sore and tired eyes as determined by impact of dry eye on everyday living-symptom bother (IDEEL-SB) questionnaire, and IDEEL-SB score 16-65 were included. Subjects were required to complete IDEEL-SB and DEQ-5 at days 0, 14 ± 2, and 28 ± 2, and self-administer one drop of PG-HPG four times daily for 28 ± 2 days. Primary endpoints were change from baseline at day 28 in symptoms of sore, stinging/burning, and tired eyes on IDEEL-SB; and symptom of watery eyes on DEQ-5. Other endpoints evaluated were corneal staining and TBUT at baseline and day 28 ± 2; symptom relief (5-point Likert scale) at day 28 ± 2, and safety.ResultsOf 119 subjects enrolled, 95 completed the study (mean ± SD age 61.2 ± 13.0 years; female 69.5%). Mean IDEEL-SB scores reduced significantly from baseline at day 28 for symptoms of aching/sore eyes (change from baseline - 1.0 ± 1.1), burning/stinging eyes (change from baseline - 1.1 ± 0.9), and tired eyes (change from baseline - 1.1 ± 1.0) (all p < 0.0001). Mean DEQ-5 score for watery eye symptoms significantly reduced from baseline at day 28 (change from baseline - 0.9 ± 1.0, p < 0.0001). Corneal staining at day 28 was comparable to baseline. TBUT improved from baseline to day 28. On a Likert scale, more than 50% of subjects reported relief from symptoms of sore, stinging, and burning eyes. Three (3.1%) subjects reported treatment-emergent adverse events (non-ocular).ConclusionsPG-HPG nanoemulsion lubricant eye drops significantly improved multiple dry eye symptoms in subjects with DED over 28 days, with no new safety concerns.Trial registrationClinicalTrials.gov Identifier, NCT05056155.

Project description:Dry eye disease (DED) is multifactorial, affecting 5-34 % of the global adult population and reducing quality of life. The artificial tears or lubricants are the therapy most used for the treatment of DED, due to their low side effect profile, which attempt to modify the properties of the tear film. The aim of the present study was to evaluate the clinical efficacy of a fixed combination of xanthan gum and chondroitin sulfate preservative free on the ocular surface of patients with dry eye disease during 60 days of intervention.A phase III, double-blind, masked, controlled, multicenter, clinical trial of 148 subjects, randomized to either a fixed combination of xanthan gum 0.09 % and chondroitin sulfate 0.1 % (XG/CS) ophthalmic solution (n?=?76) or a fixed combination of polyethylene glycol 400 0.4 % and propylene glycol 0.3 % (PEG/PG) (n?=?72). Subjects self-dosed four times daily during 60 days. Follow-up was set on days 2, 7, 15, 30 and 60. Assessments of anterior/posterior segment ocular signs were performed. The outcome measures included Schirmer test, tear film break-up time and OSDI score. Security variables included intraocular pressure, lisamine green and fluorescein ocular surface stains.The primary efficacy endpoints were similar between groups at baseline. After intervention time Schirmer test increased in both groups compared to baseline, XG/CS (6.4?±?2.2 vs 11.0?±?6.6; p?=?0.002) and PEG/PG (6.5?±?2.5 vs 10.5?±?5.6; p?=?0.019) respectively. Similar results were reported in the tear film break-up time in XG/CS (5.5?±?2.1 vs 7.4?±?2.9; p?=?0.027) and PEG/PG (5.2?±?2.0 vs 7.4?±?2.7; p?=?0.046) respectively. The OSDI score decreased to normal values in both groups, XG/CS (19.3?±?7.4 vs 7.3?±?5.9; p?=?0.001) and PEG/PG (19.3?±?7.5 vs 7.9?±?8.2; p?=?0.001) respectively. There was no significant difference between treatments for any parameter. Moreover, both groups decreased the presence of burning sensation, tearing, foreign body sensation, conjunctival hyperemia and photophobia. The adverse events were not related to the interventions.Xanthan gum/chondroitin sulfate preservative free showed similar clinical efficacy, evaluated with OSDI score, TBUT and Schirmer test compared to polyethylene glycol/propylene glycol in the treatment of dry eye disease.ClinicalTrials.gov: NCT01657253 . Date of registration May 19, 2014.

Dataset Information

Impact of polyethylene glycol 400/propylene glycol/hydroxypropyl-guar and 0.1% sodium hyaluronate on postoperative discomfort following cataract extraction surgery: a comparative study.

Background

Methods

Results

Conclusion

Trial registration

Publications

Impact of polyethylene glycol 400/propylene glycol/hydroxypropyl-guar and 0.1% sodium hyaluronate on postoperative discomfort following cataract extraction surgery: a comparative study.

Similar Datasets

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