Initial Clinical Experience with Ahmed Valve in Romania: Five-Year Patient Follow-Up and Outcomes

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

In general, the article is very detailed, and it can be seen that there is real research, from diagnosis, treatment and complications, every special point is described in detail, but the whole running account has no focus and no highlights.

 

1. It is recommended to use charts to represent the description of the surgical process;

 

2. The whole article does not mention whether mitomycin was used during the operation and the reason for not using it;

 

3. The distribution of patients undergoing glaucoma surgery in the results can be simply described in the table without detailed description;

 

4. The postoperative intraocular pressure part shown in Figure 1 is too simple, and at least standard discriminant statistical analysis should be performed.

 

5. 171-180 The expression of the first, second and third patients is not clear when corresponding to the number of patients in the table.

 

6. It is recommended to list surgical complications in the form of charts.

 

 

The proportion of references within 5 years is too small.

Author Response

Thank you for your insightful review.

1. It is recommended to use charts to represent the description of the surgical process;

I agree, you can find the updated chart for all the surgical steps on the 4th page.

2. The whole article does not mention whether mitomycin was used during the operation and the reason for not using it;

I mentioned that we did not use Mytomicin and why. It is written in bold (126-130)

3. The distribution of patients undergoing glaucoma surgery in the results can be simply described in the table without detailed description;

I removed some of the description and the table 1 can be found on page 5.

4. The postoperative intraocular pressure part shown in Figure 1 is too simple, and at least standard discriminant statistical analysis should be performed.

I updated the figure 1 and added a detailed description of the table (213-223).

5. 171-180 The expression of the first, second and third patients is not clear when corresponding to the number of patients in the table.

I agree, the numbers in the table were corrected.

6. It is recommended to list surgical complications in the form of charts
   Surgical complications were added as a chart, Figure 3, page 9.

Also, the references within 5 years has been updated.

Reviewer 2 Report

Comments and Suggestions for Authors

This is a valuable study in which the researchers describe the 5-year clinical findings of the Ahmed Valve for refractory glaucoma, evaluating its effectiveness, associated complications, and overall patient outcomes. The manuscript is well structured, clear, and readable, but there is still some room for improvement.

1. As a prospective study, whether the study was registered and whether ethical approval was obtained from the host institution before it was conducted.

2. For the protection of the reasonable rights and interests of the subjects, there must be a rigorous process of sample size calculation before the study was conducted. This is not mentioned in the manuscript and the authors are requested to elaborate.

3. What is the specific definition of refractory glaucoma? It is suggested that this be presented in the manuscript.

4. Are there any cases of missing visits and missing data in the process of this study? Please elaborate on the cases of missing visits of the study subjects and the methods to deal with them.

5. The main research observations in this study were intraocular pressure and visual acuity, and whether or not to pay attention to the changes in the patients' visual field examination results.

6. Corneal endothelial cell loss and ultimately corneal dystrophy is one of the serious complications of glaucoma drainage device implantation; as a follow-up study that followed patients for 5 years, were changes in postoperative corneal endothelial cell density observed during follow-up?

7. The percentage of references within the last five years in this manuscript is slightly low, and it is suggested to improve it.

Author Response

1. As a prospective study, whether the study was registered and whether ethical approval was obtained from the host institution before it was conducted.

The study was registered and the ethical approval was obtained from the host institution. 159-160

1. For the protection of the reasonable rights and interests of the subjects, there must be a rigorous process of sample size calculation before the study was conducted. This is not mentioned in the manuscript and the authors are requested to elaborate.

The materials and methods section was updated. The requested specifications can be found 73-77, 102-122

1. What is the specific definition of refractory glaucoma? It is suggested that this be presented in the manuscript.

The definition was added in the introduction, 35-36

1. Are there any cases of missing visits and missing data in the process of this study? Please elaborate on the cases of missing visits of the study subjects and the methods to deal with them.

During the study, three patients dropped out due to death, and five patients missed follow-up visits. For patients who missed visits, the last observation carried forward method was employed to handle missing data, ensuring the robustness of the analysis. 87-90

This problem was addressed in the discussion section as well 458-472.

1. The main research observations in this study were intraocular pressure and visual acuity, and whether or not to pay attention to the changes in the patients' visual field examination results.

Visual field examination results were not tracked as a parameter because the target was to decrease IOP. Moreover, the patients included in the study had mostly significant low acuity and visual field loss at the beginning of the study, thus substantial visual field changes were not anticipated as primary outcomes. The primary intervention goal was to stabilize and lower IOP to prevent further progression of glaucoma. 154-158

1. Corneal endothelial cell loss and ultimately corneal dystrophy is one of the serious complications of glaucoma drainage device implantation; as a follow-up study that followed patients for 5 years, were changes in postoperative corneal endothelial cell density observed during follow-up?

Corneal endothelial cell loss was not tracked which is a limitation, but we investigated the position of the tube in the AC in all patiens with gonioscopy.477-480

1. The percentage of references within the last five years in this manuscript is slightly low, and it is suggested to improve it.

The reference list was updated.

Reviewer 3 Report

Comments and Suggestions for Authors

1. The abstract should not contain any abbreviations.

 

2. The introduction requires references.

 

3. Where are the disclosure criteria located?

 

4. Where are the data collection procedures documented?

 

5. What are the parameters used to determine the sample size?

 

6. The discussion should correlate the incidence of glaucoma with age and gender.

 

7. The discussion should focus on the prognosis of the case after the 5-year postoperative period.

 

8. The references need to be updated.

Comments on the Quality of English Language

1. The grammar and punctuation should be revised.

Author Response

Thank you for your insightful review. 

The abstract should not contain any abbreviations.

All abbreviations were removed from the abstract.

2. The introduction requires references.

References have been added in the introduction. All the added text is written in bold.

3. Where are the disclosure criteria located?

It can be found on page 13.

4. Where are the data collection procedures documented?

The data collection procedures are documented in patients' paper forms in the hospital's archive. 

5. What are the parameters used to determine the sample size?

These parameters can be found on page 3, 102-117.

- the anticipated difference in the primary outcome measure between baseline

and post-intervention.

- the effect size was estimated based on previous studies and clinical expectations

of the Ahmed Glaucoma Valve (AGV) effectiveness

- an estimate of the proportion of participants who might drop out of the study or

miss follow-up visits.

- based on similar studies, an anticipated dropout rate of approximately 10% was

factored into the sample size calculation to account for potential loss to follow-up.

- the prevalence of refractory glaucoma and the availability of eligible patients

within the recruitment period.

- feasibility and resource constraints were also considered to ensure the study

could be practically conducted within the specified timeframe.

6. The discussion should correlate the incidence of glaucoma with age and gender.

Correlating the incidence of glaucoma with age and gender, we found that our patient cohort predominantly consisted of older adults, with a higher prevalence in males. This demographic trend aligns with existing literature indicating that age and male gender are significant risk factors for glaucoma. 384-387

7. The discussion should focus on the prognosis of the case after the 5-year postoperative period.

Analyzing the trends and patterns observed in this study suggests several underlying mechanisms and relationships. The high incidence of secondary glaucoma post-vitreoretinal surgery indicates a strong association between retinal interventions and subsequent glaucoma development. The significant reduction in IOP and medication dependency post-AGV implantation underscores the valve's effectiveness in managing refractory cases. Moreover, the complications profile highlights the need for meticulous surgical techniques and postoperative management to mitigate risks. The correlation between patient demographics and glaucoma incidence emphasizes the importance of tailored treatment approaches based on age and gender, acknowledging these as critical factors in disease progression and management outcomes.

The prognosis of patients after the 5-year postoperative period was generally positive, with sustained IOP control and reduced medication dependency. However, long-term monitoring is crucial to manage potential late-onset complications and to ensure the continued success of the AGV implantation. 481-494

8. The references need to be updated.

References from last 5 years have been updated. 

Reviewer 4 Report

Comments and Suggestions for Authors

1. Kindly add separate research gap as a sub-section could improve the article's strength as well as offer novelty.  Add a clear motivation, gap, and research question in the introduction.

2. Expand the introduction to provide a more comprehensive overview of the use of Ahmed Valve implants globally, their efficacy, and how this experience compares to international standards.

3. Clarify the methodology section to explicitly detail the patient selection criteria, inclusion/exclusion criteria, and rationale for choosing the Ahmed Valve over other treatment options.

4. Discuss patient compliance with post-operative care protocols and its potential impact on long-term outcomes, highlighting any adherence challenges encountered during the study.

5. Kindly add clear and comprehensive explanation of the figure 1 content, purpose, and implications.

6. Discuss each table in text in citation it's essential to provide a detailed commentary that clarifies the data presented, and interprets key findings.

7. While you've presented the basic findings in the result, please consider delving deeper into the implications of these results.

8. What do they mean in the context of the research question? The results are interesting, but could benefit from more interpretation. What do the trends and patterns suggest about the underlying mechanisms or relationships?

9. To strengthen the paper, please incorporate recent advances and findings in the field by including latest references

Comments on the Quality of English Language

Moderate editing is required.

Author Response

Thank you for your insightful review.

Kindly add separate research gap as a sub-section could improve the article's strength as well as offer novelty.  Add a clear motivation, gap, and research question in the introduction.

The introduction has been updated. Our findings are expected to contribute significantly to the global body of knowledge on glaucoma management, offering a unique perspective from a Romanian cohort and adding to the diversity of clinical experiences with the AGV. The insights gained from this study will not only enhance clinical practice in Romania but also provide valuable data for ophthalmologists worldwide who are managing patients with refractory glaucoma.66-71

Expand the introduction to provide a more comprehensive overview of the use of Ahmed Valve implants globally, their efficacy, and how this experience compares to international standards.

The introduction has been updated. Comparation with other studies has also been incorporated, 37-65.

Clarify the methodology section to explicitly detail the patient selection criteria, inclusion/exclusion criteria, and rationale for choosing the Ahmed Valve over other treatment options.

The methodology section has been updated as well. The criteria and rationale can be found on page 2, 77-86.

Discuss patient compliance with post-operative care protocols and its potential impact on long-term outcomes, highlighting any adherence challenges encountered during the study.

The challanges of patients' compliance have been added in the Discussion section, 11-12 (458-472).

Kindly add clear and comprehensive explanation of the figure 1 content, purpose, and implications.

The figure has been updated and comments were added (222-232).

Discuss each table in text in citation it's essential to provide a detailed commentary that clarifies the data presented, and interprets key findings.

Table 1. has the detailed commentary above, for instance why the majority of our patients have secondary glaucoma due to vitreoretinal surgery. 
For figure 2. , as answered in the previous question, I added the discussion below it. 222-232.

For table 3. I added the commentary below (360-366)

While you've presented the basic findings in the result, please consider delving deeper into the implications of these results.

The results and discussion sections were updated. The added information is written in bold. It addresses the analysis of our results, comparation with other studies and other forms of treatment, specifically cyclophotocoagulation, the disscusion on patients' postoperative compliance, trend and patterns analysis and prognosis after 5-year postoperative period. 

What do they mean in the context of the research question? The results are interesting, but could benefit from more interpretation. What do the trends and patterns suggest about the underlying mechanisms or relationships?

Analyzing the trends and patterns observed in this study suggests several underlying mechanisms and relationships. The high incidence of secondary glaucoma post-vitreoretinal surgery indicates a strong association between retinal interventions and subsequent glaucoma development. The significant reduction in IOP and medication dependency post-AGV implantation underscores the valve's effectiveness in managing refractory cases. Moreover, the complications profile highlights the need for meticulous surgical techniques and postoperative management to mitigate risks. The correlation between patient demographics and glaucoma incidence emphasizes the importance of tailored treatment approaches based on age and gender, acknowledging these as critical factors in disease progression and management outcomes. 481-490

To strengthen the paper, please incorporate recent advances and findings in the field by including latest references

The references from the last 5 years have been added. 

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

The manuscript can be accepted.

Reviewer 4 Report

Comments and Suggestions for Authors

The authors have well addressed the comments that I presented. I recommend accepting this paper at its current form.