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   Table of Contents      
LETTER TO THE EDITOR
Year : 2016  |  Volume : 64  |  Issue : 8  |  Page : 614-615

Comment on: Role of subconjunctival bevacizumab in primary pterygium surgery


1 Department of Community Medicine, Yenepoya Medical College, Yenepoya University, Mangalore, Karnataka, India
2 Department of Ophthalmology, Yenepoya Medical College, Yenepoya University, Mangalore, Karnataka, India

Date of Web Publication30-Sep-2016

Correspondence Address:
Dr. Siddharudha Shivalli
Department of Community Medicine, Yenepoya Medical College, Yenepoya University, Mangalore - 575 018, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0301-4738.191516

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How to cite this article:
Shivalli S, Kaup S. Comment on: Role of subconjunctival bevacizumab in primary pterygium surgery. Indian J Ophthalmol 2016;64:614-5

How to cite this URL:
Shivalli S, Kaup S. Comment on: Role of subconjunctival bevacizumab in primary pterygium surgery. Indian J Ophthalmol [serial online] 2016 [cited 2020 May 29];64:614-5. Available from: http://www.ijo.in/text.asp?2016/64/8/614/191516

Sir,

Singh et al. [1] conducted a randomized controlled trial (RCT) to evaluate the effect of subconjunctival injection of bevacizumab in a single dose followed by surgical excision of pterygium with conjunctival autograft after 1 week. They concluded that no statistically significant (P > 0.05) reduction in the recurrence of pterygium by bevacizumab. Authors' efforts are commendable and they should be congratulated for publishing the negative results. This is essential to yield an unbiased result if one undertakes a systematic review and meta-analysis on this topic. However, following issues and concerns need to be addressed.


  Clinical Trial Registration Top


Since June 2009, Drugs Controller General of India has made it mandatory to register the trial in Clinical Trial Registry of India (CTRI). [2] However, the CTRI number for this study is not reflected in the article.


  Consolidated Standards of Reporting Trail Statement Top


Consolidated Standards of Reporting Trail (CONSORT) statement is an evidence-based, minimum set of recommendations for reporting randomized trials. [3] CONSORT statement consists of a flow diagram and a 25-item checklist. It is endorsed by many of the prominent medical journals and leading editorial organizations. However, authors have not included a CONSORT flow diagram. According to the flow diagram, one should mention the number of participants assessed for eligibility and how many were excluded and the reasons for exclusion. Authors state that 60 eyes with primary pterygium of 60 patients (30 in each group) were enrolled in this study. According to CONSORT checklist, authors should have explained how the sample size was determined. [3] The power (1-β) of this study is very low (0.51) [4] with a sample size of 60 (30 in each group), even expecting a 20% absolute reduction in pterygium recurrence with subconjunctival bevacizumab when compared to 30% in control group. This may compromise the external validity of the findings.

Authors state that the study was a prospective, comparative, triple-blinded, randomized control study. In our opinion, it is better to explicitly spell out who were blinded in the RCT (i.e., study participant, random group allocator, operating surgeon, data collector, outcome assessor, statistician, etc.).

Clinicians' efforts, despite busy schedule, to conduct an RCT must be applauded. However, the quality of evidence generated may not be good enough to influence the clinical decision making if methodological issues are not addressed. Hence, following standard guidelines for conducting and reporting an RCT are imperative.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Singh P, Sarkar L, Sethi HS, Gupta VS. A randomized controlled prospective study to assess the role of subconjunctival bevacizumab in primary pterygium surgery in Indian patients. Indian J Ophthalmol 2015;63:779-84.  Back to cited text no. 1
[PUBMED]  Medknow Journal  
2.
Clinical Trials Registry - India (CTRI); 2016. Available from: http://www.ctri.nic.in/Clinicaltrials/cont1.php. [Last cited on 2016 Jan 31].  Back to cited text no. 2
    
3.
Consort - Welcome to the CONSORT Website; 2016. Available from: http://www.consort-statement.org/. [Last cited on 2016 Jan 31].  Back to cited text no. 3
    
4.
Chow S, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2 nd ed. Boca Raton, Florida: Chapman and Hall/CRC Biostatistics Series; 2008. p. 89.  Back to cited text no. 4
    




 

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