The Efficacy Of Post-Operative Lubricating Drops To Limit Dry Eye Disease Symptoms And Signs Following Cataract Surgery: Preliminary Data Of A Randomised Control Trial

Modern micro-incision cataract surgery (CS) can lead to disruption of the tear film homeostasis, leading to development of dry eye disease (DED) symptoms. In this study we investigated the effects of routine prophylactic lubricating eye drops for six weeks following CS, compared to standard treatment alone and baseline (pre-operative) measurements.

Patients with no history of DED were recruited and randomised into the standard care group (SCG) (n=29) (dexamethasone and chloramphenicol eye drops for 4 weeks) or intervention group (IG) (n=25) where patients received additional lubricating drops for 6 weeks. Primary outcomes were DED symptom questionnaire (SPEED II) and patient reported outcome measures (CATPROM-5 and EQ-5D-3L). Secondary outcomes included uncorrected distance visual acuity (UDVA), best corrected visual acuity (BCVA), automated non-invasive tear break-up time (NTBUT), Schirmer I test (ST), tear meniscus (TM), ocular surface staining (OST), and automated percentage of meibomian gland dropout (MGD). Follow up was at two weeks and two months post-surgery. 

The median baseline, 2- and 8-weeks (w) SPEED II scores were 2 (0-12), 2 (0-8), 2 (0-19) in the SCG, and 2.5 (0-10), 2 (0-9), 2 (0-8) in the IG, with 8w SPEED II scores superior to baseline in the IG (p=0.023). In the SCG, NTBUT and TM were improved at 8w, while TM was improved at 2w in the IG from baseline. The CATPROM-5 scores were superior at 2w and 8w (p<0.0001) compared to baseline in both groups. In the SC group, there were no differences in the EQ5D3L scores compared to baseline whereas in the IG the median EQ5D3L raw score was higher compared to baseline (p=0.02). There were no differences between the two groups at baseline, 2w or 8w in any of the primary or secondary outcomes between the two groups.

Our preliminary results indicate that in routine small-incision phacoemulsification cataract surgery in patients without known DED, there are no adverse changes post-operatively in measured DED parameters. Although Speed II scores were significantly improved at 8 weeks in the IG, there were no differences between the primary and secondary outcomes between the groups, suggesting that post-operative lubricant drops after routine CS in eyes without known DED do not seem to be required in preventing post-CS DED symptoms. Further data acquisition continues.