|LETTER TO THE EDITOR
|Year : 2016 | Volume
| Issue : 8 | Page : 614-615
Comment on: Role of subconjunctival bevacizumab in primary pterygium surgery
Siddharudha Shivalli1, Soujanya Kaup2
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 Publication||30-Sep-2016|
Dr. Siddharudha Shivalli
Department of Community Medicine, Yenepoya Medical College, Yenepoya University, Mangalore - 575 018, Karnataka
Source of Support: None, Conflict of Interest: None
|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
Singh et al.  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|| |
Since June 2009, Drugs Controller General of India has made it mandatory to register the trial in Clinical Trial Registry of India (CTRI).  However, the CTRI number for this study is not reflected in the article.
| Consolidated Standards of Reporting Trail Statement|| |
Consolidated Standards of Reporting Trail (CONSORT) statement is an evidence-based, minimum set of recommendations for reporting randomized trials.  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.  The power (1-β) of this study is very low (0.51)  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.
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Conflicts of interest
There are no conflicts of interest.
| References|| |
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.
Chow S, Shao J, Wang H. Sample Size Calculations in Clinical Research.
ed. Boca Raton, Florida: Chapman and Hall/CRC Biostatistics Series; 2008. p. 89.