A Cross-Over Randomized Controlled Clinical Trial for Evaluation of Two Hygiene Protocols on Microbial Load, Tissue Health, and Opinion of Ocular Prosthesis Wearers
, LetÃcia de Sá Evelin, Viviane de Cássia Oliveira, Ana Paula Macedo, Evandro Watanabe and Cláudia Helena Silva-Lovato *Round 1
Reviewer 1 Report
Comments and Suggestions for AuthorsVery well conducted study.
Line 342-347 shows repeated sentences.
It would be helpful to describe the patients' pre-existing regimens at baseline (before enrollment), and how these differed between groups, in case it influenced the patient's perception of the assigned protocol.
Comments on the Quality of English LanguageModerate English editing would improve the paper.
Author Response
Response Letter
ManuscriptID hygiene-2629816: A cross-over randomized controlled clinical trial for evaluation of two hygiene protocols on microbial load, tissue health and opinion of ocular prosthesis wearers
Submission to Hygiene
Dear Editor and Reviewers,
We want to thank you for your attention in revising our work, and we appreciate the given comments and suggestions.
We elaborated this letter as a point-by-point response for the reviewers. The suggestions were considered, and our answers to each were written below in blue. Also, a minor English review was done. The alterations or additions to the manuscript's text were written with the yellow highlight.
We hope to have reached your expectations.
Respectfully,
The authors.
_____________________________________________________________________
Reviwer #1
Very well conducted study.
Suggestion #1: “Line 342-347 shows repeated sentences”.
Answer: Thank you very much for the observation. The changes were included.
Text Change: Regarding patients’ opinions, both protocols were well accepted by patients who finalized the study. However, 3 individuals allocated in WPt withdrew because they had not adapted to the weekly removal of the prostheses. It´s likely that the occupation of the patient influenced the cleaning habits of the prosthesis due patients who work, had daily cleaning habits for their prostheses while retired patients had weekly cleaning habits [25] possibly due to greater exposure to environmental factors. So, it is important to under-stand that some patients may have a personal preference due to specificities, like professional occupation and daily habits. The professionals must be able to adapt their proto-cols in these situations without losing their effectiveness.
Suggestion #2: “It would be helpful to describe the patients' pre-existing regimens at baseline (before enrollment), and how these differed between groups, in case it influenced the patient's perception of the assigned protocol”.
Answer: We appreciate the reviewer observation. The information about frequency hygiene was described at the Table 2. However, it was not possible to make comparisons due to the number of responses for each option. The table 2 was redone, but it was not possible to replace it in the paper file due to formatting. It was forwarded and placed below.
Text Change:
|
Gender |
Origin |
||||
|
Male |
14 (46) |
Ribeirão Preto |
8 (27) |
||
|
Female |
16 (54) |
Nearby Cities |
22 (73) |
||
|
|
|
Age |
|
||
|
18-39 |
5 (17) |
50-59 |
6 (20) |
||
|
40-49 |
8 (27) |
60+ |
11 (36) |
||
|
Time of loss |
Cause of Eye Loss |
||||
|
0 to 10 |
9 (30) |
Pathology |
14 (47) |
||
|
11 to 30 |
10 (33) |
Trauma |
14 (47) |
||
|
31+ |
11 (37) |
Congenital |
2 (6) |
||
|
Prosthesis type |
Eye drop use |
||||
|
Industrialized |
63 (19) |
Yes |
9 (30) |
||
|
Customized |
37 (11) |
None |
21 (70) |
||
|
Patient referral |
Surgery |
||||
|
Hospital |
24 (80) |
Enucleation |
16 (53) |
||
|
Internet |
3 (10) |
Evisceration |
13 (44) |
||
|
Directly |
2 (7) |
None |
1 (3) |
||
|
HUS* |
1 (3) |
||||
|
Frequency of prosthesis cleaning (Baseline) |
Cleaning agent (Baseline) |
||||
|
Non reported |
7 (23) |
Neutral soap |
7 (24) |
Baby Shampoo (BS) |
3 (10) |
|
Daily (1 to 5 times a day) |
14 (47) |
Common soap (CS) |
6 (20) |
BS and saline |
1 (3) |
|
Weekly (1 to 2 times a week) |
6 (20) |
CS and saline |
2 (6) |
Saline only |
2 (6) |
|
Monthly (1 to 2 times a month) |
3 (10) |
CS and boric acid |
1 (3) |
Water only |
8 (27) |
Table 2. Sociodemographic and clinical information of the participants in absolute number and percentage (%).
*Health Unic System; Cleaning agent: substances the patients used for their usual cleaning routine of the prosthesis.
Author Response File: 
Author Response.pdf
Reviewer 2 Report
Comments and Suggestions for AuthorsThis is an interesting study where the researchers did a clinical trial to evaluate the microbial load, tissue health of the socket, and the participants opinion before and after of the use of two hygiene protocols. Some comments.
Abstract
Please present the conclusion in a better way.
Introduction
Add more on the improvement of the personal and social aspect after the fabrication of ocular prosthesis in ocular defect patients.
https://www.sciencedirect.com/science/article/pii/S1013905213000710
Method
The researchers studied the cleaning the ocular prosthesis with neutral soap (Pleasant; Perol) once a day or WPt that consisted in the cleaning the ocular prosthesis with neutral soap (Pleasant; Perol) once a week. But in practical, many patients remove the prosthesis once a month and clean the prosthesis unlike the denture which needs to be removed daily for cleaning. The frequent removal causes ocular prosthesis causes the lower lid laxity which is a major complication in anopthalmic socket. Please consider these things.
Discussion
More discussion regarding the patient satisfaction is needed.
https://pubmed.ncbi.nlm.nih.gov/35323229/
https://doi.org/10.3390/prosthesis2020010
Conclusion
Please present in a better way.
Comments on the Quality of English LanguageMinor editing of English language required
Author Response
Response Letter
ManuscriptID hygiene-2629816: A cross-over randomized controlled clinical trial for evaluation of two hygiene protocols on microbial load, tissue health and opinion of ocular prosthesis wearers
Submission to Hygiene
Dear Editor and Reviewers,
We want to thank you for your attention in revising our work, and we appreciate the given comments and suggestions.
We elaborated this letter as a point-by-point response for the reviewers. The suggestions were considered, and our answers to each were written below in blue. Also, a minor English review was done. The alterations or additions to the manuscript's text were written with the yellow highlight.
We hope to have reached your expectations.
Respectfully,
The authors.
Reviewer #2
This is an interesting study where the researchers did a clinical trial to evaluate the microbial load, tissue health of the socket, and the participants opinion before and after of the use of two hygiene protocols. Some comments.
Suggestion #1: “Abstract
Please present the conclusion in a better way”.
Answer: We appreciate your recommendation, and the conclusion section of the abstract was improved.
Text Change: The protocols showed no effects on the microbial load of the anophthalmic socket and ocular prosthesis. However, better tissue health and patient acceptance were observed after both regimens.
Suggestion #2: “Introduction
Add more on the improvement of the personal and social aspect after the fabrication of ocular prosthesis in ocular defect patients.
https://www.sciencedirect.com/science/article/pii/S1013905213000710”
Answer: Thank you for your suggestion. The article was inserted in the introduction section, at the beginning of the 1st paragraph.
Text Change: The rehabilitation with an ocular prosthesis positively impacts quality of life by restoring appearance and social functioning [1]. However, some complications related to rehabilitation can occur while using an ocular prosthesis.
Suggestion #3: “Method
The researchers studied the cleaning the ocular prosthesis with neutral soap (Pleasant; Perol) once a day or WPt that consisted in the cleaning the ocular prosthesis with neutral soap (Pleasant; Perol) once a week. But in practical, many patients remove the prosthesis once a month and clean the prosthesis unlike the denture which needs to be removed daily for cleaning. The frequent removal causes ocular prosthesis causes the lower lid laxity which is a major complication in anopthalmic socket. Please consider these things”.
Answer: We appreciate your observation. These appointments were considered in discussion of the paper.
Text change: Recommendations for the use, removal, and cleaning of the ocular prosthesis may vary between professionals [43]. This fact can also be observed by the heterogenous habits of our sample at baseline. Studies have demonstrated an association between a frequent removal or cleaning of the prosthesis with socket discomfort, inflammation, discharge, and lid abnormalities [3,12,16]. However, these observations are in contrast with other studies that showed that patients who performed daily hygiene had fewer problems with the anophthalmic socket [25], and symptoms of discomfort were not correlated with hygiene habits but with the presence of pathogenic microorganisms [24]. The relationship direction between frequency of cleaning and eyelid abnormalities or discharge, for example, is still not clear, since both problems have multifactorial causes. Lid abnormalities can be associated with many other variables, such as aging, surgical complications, inadequate implant size, and heavy ocular prosthesis [44], and their appearance can be a clinical course of those complications. Discharge can be associated with tear film impairment or morphological alterations of the lacrimal apparatus [21, 24]. So, there is a clear importance of the development of longitudinal studies and clinical trials to assess effectively the relationship between prosthesis insertion, hygiene regimen, and signs and symptoms of anophthalmic socket. Also, a protocol establishment is important, with regular care, to avoid inadequate care of the patients (such as an excess or a lack of hygiene) and a protocol that considers the exposure to external environmental factors [20].
43 Osborn, K.L., Hettler, D. A survey of recommendations on the care of ocular prostheses. Optometry. 2010 Mar;81(3):142-5. doi: 10.1016/j.optm.2009.11.003.
44 Pine, K.R.; Sloan, B.H.; Jacobs, R.J. Socket Complications: Complications of Prosthesis Retention. In Clinical ocular prosthetics. Publisher: Springer International Publishing. Berlin, Germany 2015; p.180-186.
Suggestion #4: “Discussion
More discussion regarding the patient satisfaction is needed.
https://pubmed.ncbi.nlm.nih.gov/35323229/
https://doi.org/10.3390/prosthesis2020010”
Answer: The objective of our study was to evaluate patients' opinions regarding the hygiene protocols implemented, with daily hygiene and weekly hygiene. In other words, there was no intervention regarding the replacement or adjustment of ocular prostheses. The first recommended article investigated the magnification of the iris in the ocular prosthesis with various thicknesses of clear heat cure acrylic resin. The second article evaluated the influence of ocular discomfort and meibomian gland dysfunction (MGD) on quality of life in patients with an ocular prosthesis.
Although they do not have a direct relationship with the objectives of our study, the second article was considered in the discussion.
If the reviewer believes that any change may still be relevant, we would like more information and more specifics as to what we can change.
Text Change: The signs of inflammation and discharge on the anophthalmic socket can be caused by many factors, including poor fitting and finishing of the ocular prosthesis [8,16,17,21,41], biofilm adhesion [26,27,32,33], bacterial or viral infections [4,5], frequent removal of the prosthesis [2,3,16], surgical complications such as implant exposure or pyogenic granuloma [4,5,9], alterations on meibomian glands and poor lubrication of the socket [4,5,13,15,20], and exposure to adverse environmental conditions like dry weather and air conditioner [20,41,42].
Suggestion #5: “Conclusion
Please present in a better way”.
Answer: We appreciate your recommendation, and the conclusion section was improved.
Text Change: Regardless of the daily or weekly hygiene, both protocols did not show an influence on the microbial load on the prostheses and of the socket but improved the tissue health of the anophthalmic socket, specifically on inflammation signs and discharge production. In addition, the patients manifested satisfactory opinions about both protocols tested.
Round 2
Reviewer 2 Report
Comments and Suggestions for Authorsthank you for the revision
Comments on the Quality of English Languageminor editing needed
