Enbucrilate

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented publication which meets basic scientific principles

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2005

Materials and methods

Endpoint addressed:

eye irritation

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Retrospective case series

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Isobutyl cyanoacrylate

IUPAC Name:

Isobutyl cyanoacrylate

Test material form:

other: liquid

Details on test material:

- Isobutyl cyanoacrylate (Iso-Dent, Ellman Int. Inc., New York)

Method

Ethical approval:

other: retrospective study, treatment at Duke University (1996-2002) performed after obtaining institutional review board exemption

Details on study design:

The charts of 20 patients (22 eyes) with corneal perforation <=3mm in size treated with isobutyl cyanoacrylate tissue adhesive were reviewed for etiology of perforation, visual outcome and complications.

Exposure assessment:

not specified

Details on exposure:

Of 70 patients with corneal perforations <=3mm, 22 eyes of 20 patients were treated with isobutyl cyanoacrylate at Duke University between 1996 and 2002. The adhesive was applied using a standard technique.

Results and discussion

Results:

Cyanoacrylate tissue adhesive is useful in the management of corneal perforation. Healing frequently occurs with the adhesive alone and no further surgical intervention is required. In this case series, isobutyl adhesive was highly effective at treating corneal perforations <=3mm in size. Additionally, the visual results in eyes treated with adhesive were excellent and, in this study, similar to those attained in eyes that underwent PK.
The experience of this study suggests that the use of cyanoacrylate tissue adhesive for corneal perforation can lead to healing, provide excellent visual results, and offer a useful alternative to surgery.

Any other information on results incl. tables

Nine (40.9%) of the 22 eyes healed with application of tissue adhesive. The mean interval of time needed for healing was 33.4 days (range 4 to 80 days; median 34 days). Seven eyes (31.8%) proceeded to PK with the adhesive in place. PK was performed not as a result of adhesive failure, but because of the belief that it offered improved visual potential. The mean time from adhesive application to PK was 33 days (range, 1 to 109 days; median 14 days). Four eyes had adhesive in place at the final follow-up visit (mean 187 days; range 75 to 270 days; median 201 days) and two patients were lost to follow-up. The most common complication was the need for reapplication in six eyes (27.3%) because of recurrent leaks or glue dislodgement. Of those eyes, three (50%) healed, two (33%) underwent PK, and one (17%) had glue in place at final follow-up. There was no case of endophthalmitis despite the fact that two patients had perforated bacterial keratitis.

Of the nine eyes that healed with tissue adhesive alone, best-corrected visual acuity (BCVA) improved in seven (77.8%) and remained stable in two (22.2%). In these eyes, mean BCVA at the time of perforation was 1.77 +/- 1.21 (logMAR scale) and at final follow-up (mean 100 days; median 240 days; range 39 to 1304 days) improved to 0.91 +/- 1.08 (P = 0.0078). Of the seven eyes that underwent PK, BCVA improved in five (71.4%), remained stable in one (14.3%), and decreased in one (14.3%). Mean BCVA at the time of perforation was 1.51 +/- 1.03 and at final follow-up (mean 739 days; median 365 days; range 120 to 2095 days) improved to 0.75 +/- 0.56 (P = 0.125). At final follow-up, there was no statistically significant difference in BCVA between eyes that healed with adhesive and those that underwent PK. Of the four eyes that had adhesive in place at final follow-up, BCVA improved in one (25%), remained stable in one (25%), and decreased in two (50%). ln these eyes, mean BCVA at perforation was 0.85 +/- 0.37 and at final follow-up (mean 187 days; median 201 days; range 75 to 270 days) 1.15 +/- 0.70 (P = 0.75).

Applicant's summary and conclusion

Conclusions:

Isobutyl cyanoacrylate tissue adhesive is highly effective at treating corneal perforations. Approximately half of the perforations <=3 mm healed and visual acuity improved in most of these eyes.

Executive summary:

METHODS

The charts of 20 patients (22 eyes) with corneal perforation <=3 mm in size treated with isobutyl cyanoacrylate tissue adhesive were reviewed for etiology of perforation, visual outcome and complications.

RESULTS

Nine of the 22 eyes (40.9%) healed with application of adhesive alone. The mean interval of time needed for healing was 33.4 days. VisuaI acuity improved in seven eyes (77.8%) and remained stable in two (22.2%). Seven eyes (31.8%) proceeded to penetrating keratoplasty (PK) with the adhesive in place. Of these, visual acuity improved in five (71.4%), remained stable in one (14.3%), and decreased in one (14.3%). Six eyes (27.3%) required more than one application of adhesive.

CONCLUSIONS

Isobutyl cyanoacrylate tissue adhesive is highly effective at trealing corneal perforations. Approximately half of the perforations <=3 mm healed and visual acuity improved in most of these eyes.