Prospective pilot randomized controlled study of mini-scleral lenses versus rigid gas permeable lenses in irregular cornea with dry eye

This single-blind prospective pilot randomized controlled study compared mini-scleral lenses (mSLs) and rigid gas-permeable lenses (RGP) in patients with irregular astigmatism and dry eye disease (DED). Forty patients (78 eyes) were fitted with mSLs (18 patients, 35 eyes) or RGP (22 patients, 43 eyes), and followed at baseline, 1 week, 1, 3 and 6 months. Evaluations included uncorrected visual acuity (UCVA), best spectacle corrected visual acuity (BSCVA), contact lens-corrected visual acuity (CLCVA), tear break-up time (TBUT), slit-lamp biomicroscopy, Anterior segment optical coherence tomography (AS-OCT), Ocular Surface Disease Index (OSDI), Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) scores and visual fluctuations. At 6 months, CLCVA was better than BSCVA in both groups (P < 0.001), with greater ∆VA (UCVA–CLCVA) improvement in RGP (P = 0.017, η2p = 0.085). Both groups showed reductions in OSDI (P = 0.001, η2p = 0.282) and CLDEQ-8 scores (P = 0.018, η2p = 0.159), with mSLs consistently showing lower CLDEQ-8 scores. Visual fluctuations were less frequent in the mSLs group (P = 0.006, η2p = 0.876). TBUT did not differ significantly. mSLs improve corrected visual acuity and provide better subjective comfort in irregular astigmatism and DED, representing a valuable treatment option. However, larger-scale studies are needed to clarify the advantages of the two contact lenses.