Evaluation Of Ocigel Coupling Agent: Tolerability, Safety, And Performance In Ophthalmic Diagnostics
Published 2026 - 44th Congress of the ESCRS
Reference: POCOR537 | Type: Free paper | DOI: 10.82333/m0th-nz57
Authors: Dr Alessandro Mularoni 1 , Dr Laura Rania* 2 , Dr Kira Mularoni 2 , Dr Elisa Boccalon 3 , Dr Umberto Rodella 3 , Dr Jana D'Amato Tothova 3
1Ophthalmology Department ,Istituto per la Sicurezza Sociale di San Marino – ISS,Città di San Marino,San Marino, 2MD UOC Oculistica,Istituto per la Sicurezza Sociale di San Marino – ISS,Città di San Marino,San Marino, 3Research and Development,AL.CHI.MI.A. SRL, Moria Group,Ponte San Nicolò,Italy
Purpose
This study aimed to evaluate the tolerability, safety, and clinical performance of OCIGEL (AL.CHI.MI.A. SRL, Moria Group, Italy), a sterile, preservative-free, viscous and transparent single-dose gel used as a coupling agent with contact diagnostic lenses in ophthalmology.
Setting
This single-center study was conducted at the Ospedale di Stato (San Marino) on 37 adults patients (≥18 years) undergoing routine ophthalmic examination requiring contact diagnostic lenses.
Methods
OCIGEL was applied directly onto the contact diagnostic lens immediately before its placement on the cornea. Bulbar redness (BR) was quantified using the Keratograph® 5M before (BR1, after addition of mydriatic and anesthetic drops, routinely used in the examination) and 15 minutes after (BR2) OCIGEL application in the treated eye, with contralateral eye as control. Clinicians rated performance parameters (adhesion, tightness, transparency, absence of bubbles, ease of application) immediately after use. Local tolerability was evaluated through a questionnaire assessing burning, itching, pain, eyelid stickiness, and blurred vision on a 1–4 severity scale immediately post-application and at 15 minutes follow-up.
Results
Mean BR exhibited a minimal, non-significant increase in treated eyes (BR1: 1.50±0.60 to BR2: 1.90±0.88) comparable to changes in control eyes (BR1: 1.68±0.59 to BR2: 1.77±0.65), indicating absence of clinically relevant irritation.
No burning, itching, pain, or eyelid stickiness (0%) were reported, either before or after OCIGEL application. One subject experienced mild, transient blurred vision that resolved rapidly after rinsing with water, with no other adverse events. Clinical performance was excellent in 36 patients (97.3%) and good in 1 (2.7%) regarding OCIGEL adhesion, tightness, and transparency (100% favorable overall) during use. No bubbles were observed during any application, that was consistently rated “easy” or “very easy”.
Conclusions
OCIGEL showed excellent tolerability, safety (no significant irritation, adverse events, or meaningful BR changes), and robust clinical performance in real-world use, confirming its suitability as a coupling gel for contact diagnostic ophthalmology. These findings substantiate OCIGEL safety and efficacy as a coupling agent with contact diagnostic lenses in ophthalmology.