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Ocular anesthetic comparison between vaporization and eyedrop instilation of tetracaina 1%.

Tetracaine 1% anesthetic effect: comparison between eye drops in open eyes and spray in closed eyes

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-4s55nj
Enrollment
Unknown
Registered
2018-11-09
Start date
2017-09-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ocular hypertension

Interventions

100 eyes from 50 patients were chosen for the administration of eye drops or vaporization according to an Excel pseudorandom number table. For each patient,one eyedrop was aplied onto one eye and a s
Drug

Sponsors

Universidade Estácio de Sá
Lead Sponsor
Universidade Estácio de Sá
Collaborator

Eligibility

Age
13 Years to 100 Years

Inclusion criteria

Inclusion criteria: All the patients who came for ophthalmological consultation in Policlínica Ronaldo Gazolla -RJ from September 2017; invitations for patient participation in the study continued until the inclusion of 50 subjects.

Exclusion criteria

Exclusion criteria: Presence of any infectious or degenerative corneal disease; presence of disease affecting the trigeminal nerve, such as herpes zoster; patients who do not understand the research procedures.

Design outcomes

Primary

MeasureTime frame
Reduction of corneal esthesiometry was greater in the control group. The differences between the groups were on average: 43% at 5 minutes, 28% at 10 minutes and 24% at 15 minutes. The variation in esthesiometr variationy as a function of time for the different application methods showed that there was an interaction between the studied factors (ANOVA for paired and replicated measures, p <0.02). ;Forty-eight percent of patients considered vaporization in their closed eyes very easy, while 6% considered it in open eye droplet instillation (table 1). Three patients (6%) reported that droplet instillation was a difficult procedure, whereas no patient reported that closed-eye vaporization was difficult or very difficult (Wilcoxon Signed-rank test, p = 0.0001). The difficulty in cooperating to instill topical anesthetics eye drops was reported by 12 (24%, 95% CI: 13.06% - 38.17%) of the patients, while the difficulty to cooperate with closed-eye vaporization was reported only by two (4%, 95% CI: 0.49% - 13.71%) patients (McNemar, p = 0.006). The most frequent difficulties related to eye drops instillation were blinking (8%), keeping the eye open (8%), burning discomfort (4%) and difficulty understanding the instillation process (2%). Patients reported only one difficulty for vaporization in the closed eye, which was that of ocular burning.; All the instilled drops reached the surface of the eyes and only one of the vaporizations did not reach the palpebral margin. The eye drops were repeated in 7 (14%, 95% CI: 5.82-26.74) and vaporization in 5 (95% CI: 3.33-21.81) patients. A mean of 1.18 drops (dp = 0.5602) and 1.1 vaporization (dp = 0.303) per patient were used (paired t-test, p = 0.3994). The tip of the eye bottle touched the eyelids or eyelashes in 10 patients (20%, 95% CI: 10.03-33.72). The fingers did not touch the vaporizer tip or ocular tissue in all patients (0%, 95% CI: 92.89-100), and this result was statistically significant (MCNemar, p = 0.

Secondary

MeasureTime frame
Despite the reduction, the authors noted that all the vaporized eyes, as well as the ones, which had droplet instillations,that realized aplanation tonometry, performed it without incident.

Countries

Brazil

Contacts

Public ContactArlindo Portes

Universidade Estácio de Sá

portes@uol.com.br+55999119955

Outcome results

None listed

Source: REBEC (via WHO ICTRP)