Pseudo-controversy is the creation of controversy or an argument when there is room for none.
Somewhere in July of 2016, a case of cluster endophthalmitis made headlines in the print media.
Blame was put on the off-label use of RL (Ringer Lactate) rather than on its sterility.
It was a senseless phobia hyped by experienced ophthalmologists even though they are very well aware
that Ringer Lactate is being used widely since decades all over the country.
Specially in such high volume institutes such Aravind Eye Care system and Shankar Netralaya.
Some comments from more sane and rational voices.
Comment 1
Usage of Ringer lactate like Avastin is off label inside the eye.If endophthalmitis occurs & we use intra vitreal Vavco/Cefta it is again off label.
Off label usage of drugs is happening all the time in Ophthalmolgy & other branches of Medicine too.DCGI , the courts & other agencies are all aware of this.
While legal sanction may not be there, they are justified by scientific evidence,peer reviewed literature & wide usage.We are all aware that it is not Avastin/RL that causes infection but contamination, which could happen with any drug that could causes a disaster.
It is not possible or necessary to react to every irresponsible news paper report or e mail post.If any of our colleagues are in trouble with the authorities we will definitely move decisively to help them.Request anyone requiring that kind of assistance to immediately contact the Governing Council (GC) of AIOS.
The GC of AIOS is meeting tomorrow & we would take a definite collective stand on this.
Dr.D.Ramamurthy,
President AIOS.
Comment 2
The irony is that using bss too does not guarantee safety in surgery. I have heard of at least 3 different instances of adverse reactions to bss made by different manufacturers ( other than Alcon) which ranged from fungal endoph to corneal decompensation due to substandard bss.
Dr Donald Lobo
Comment 3
Re published article and safety of RL
1) Both Aravind and SN are using RL for their cataract surgeries.
2) The initial corneal swelling with RL is because it is hypotonic when compared to aqueous and not due to endothelial trauma. This is why the long term corneal thickness and endoth cell counts are similar to BSS.
273 mOsmols vs 300 mOsmols
regards
Ramesh D
BSS
3H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O7. 2H2O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.0. The osmolality is approximately300 mOsm/ Kg.
RL
Ringers Lactate solution, also known as Ringer-Lockes solution, is a solution that is isotonic Ringers Lactate has an osmolarity of 273 mOsm/L. The lactate is metabolized into bicarbonate by the liver, which can help correct metabolic
Aqueous Humor
The osmolarity of the human lens is 302 mCsm and equals the osmolarity of aqueous. The soluble alpha and gamma crystallins leak into the aqueous humor ..
Comment 4
I think we urgently need more peer reviewed publications regarding safety and efficacy of RL for ophthalmic surgery from our leading institutes. IJO & AIOS must take a lead in this. Off label use is nowadays well documented for innumerable drugs from aspirin to chloroquine to intravitreal antibiotics. Manufacturer of the drug cannot possibly predict the usefulness of his drug for different indications and thereby may not be able to print each and every indication on his information leaflet.
As long as peer reviewed publications and widespread usage of a drug have shown safety and efficacy, the use of a drug is legal.More the evidence the better.
Dr Donald Lobo