Treatment for aqueous deficiency dry eyes

Not yet recruiting

• Conditions: Other disorders of lacrimal gland,

• Registration Number: CTRI/2020/12/029574
• Lead Sponsor: L V Prasad Eye Institute

Brief Summary

5-FU has been clinically used in glaucoma filtering surgeries,recurrent pterygium, and management of ocular surface squamous neoplasias.1,25FU induces apoptosis of the Tenon’s fibroblasts and has anti-proliferativefibroblastic properties. Only one retrospective study (ASOPRS abstract;unpublished) has shown promising results of 5-FU injections reducing diseaseseverity in Stevens Johnson syndrome (SJS)/ ocular cicatricial pemphigoid OCPpatients. Lacrimal glands from these patients have demonstrated scarring in theareas of ductular openings, and preserved acinar structure on histology. Ourinitial results of 5-FU injections into the palpebral lobe demonstratedimprovement in Schirmer values with one injection. However, its long-termeffects and number of repeated injections needed are unknown. The aim is tostudy the effects of 5-FU on tear secretion in SJS patients in a randomized,controlled manner.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-12
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age more than 12 years 2) Patients diagnosed with cicatrizing conjunctivitis or Stevens-Johnson syndrome or Ocular cicatricial pemphigoid having Schirmer I value between 1-5mm 3) If both eyes match the criteria, then eye with less Schirmer value would be chosen 4) Only those who choose the injection modality and give a valid consent (attached) will be enrolled into the study.

Exclusion Criteria

1. Presence of corneal epithelial defects 2) Schirmer value of zero mm 3) Any ocular surgery within past 3 months 4) Any keratoplasty or ocular surface procedure performed during the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.BCVA	1 and 3 months from the last injection
2.Ocular surface disease index	1 and 3 months from the last injection
3.Schirmer I value (without anesthesia)	1 and 3 months from the last injection
4.Corneal and conjunctival hyperemia	1 and 3 months from the last injection
5.Corneal epithelial fluorescein staining	1 and 3 months from the last injection
6.Slit lamp images- unstained, fluorescein, green filter	1 and 3 months from the last injection
7.Tear sampling for future proteomic study	1 and 3 months from the last injection

Secondary Outcome Measures

Name	Time	Method
Corneal and conjunctival hyperemia	Corneal epithelial fluorescein staining

Trial Locations

Locations (1)

L V Prasad Eye Institute; 🇮🇳 Hyderabad, TELANGANA, India

L V Prasad Eye Institute

🇮🇳Hyderabad, TELANGANA, India

DrSwati Singh

Principal investigator

7036981646

swatisingh@lvpei.org