Insular infraorbital neurovascular pedicle labial salivary gland transplantation for the treatment of severe dry eye disease: an IDEAL stage 0, 1 and 2a study.

Objectives: To address the lack of nerve and blood supply after labial salivary gland transplantation (LSGT) resulting in glandular atrophy. We designed a modified LSGT, called insular infraorbital neurovascular pedicle LSGT, and evaluated the postoperative efficacy.

Design: This is a prospective, single-centre, self-contained study.

Setting: The research was conducted at Beijing Tongren Hospital, Capital Medical University from July 2019 to March 2024.

Participants: Eight patients (nine eyes) with severe dry eye disease (DED) were enrolled in this study.

Interventions: All patients underwent insular infraorbital neurovascular pedicle LSGT and were followed up for at least 6 months postoperatively.

Main Outcome Measure: Key evaluation indices were best-corrected visual acuity (BCVA), Ocular Surface Disease Index (OSDI) score, tear break-up time (TBUT), Corneal Fluorescence Staining (CFS) score, and Schirmer I test (SIT).

Results: With a mean follow-up of 17.56±11.72 months, BCVA improved in four eyes and stabilized in five. OSDI score decreased from 59.33±14.37 to 26.27±10.14 (p<0.001). SIT improved from 0.00±0.00 mm to 5.44±2.01 mm (p<0.0001). TBUT increased from 0.23±0.48 s to 5.48±4.67 s (p=0.008). CFS scores decreased from 12.56±2.65 to 7.56±3.09 (p<0.001). All glands remained viable with good blood supply, and no serious complications were observed.

Conclusion: Insular infraorbital neurovascular pedicle LSGT for severe DED is a feasible and effective treatment, maintaining good secretory capacity and blood supply long-term.

Trial Registration Number: ChiCTR2200056015.