OCT Guided Punctal Stenosis Management

Tanta University

Status and phase: Completed; Phase 4

Conditions: Epiphora Due to Insufficient Drainage

Treatments: Drug: Methylprednisolone eyedrops

Study type: Interventional

Funder types: Other

Identifiers

NCT04318652

32399/09/18

Details and patient eligibility

About

This is a clinical trial study that was conducted on patients with punctal stenosis.We studied the diameter of stenosed puncta before and after treatment with preserved free steroid eye drops using AS-OCT.

Full description

The study was conducted on 40 eyes of 24 patients have acquired inflammatory punctal stenosis and 20 eyes of 10 patients of normal asymptomatic subjects as control group. We studied the external punctal diameter, visibility of the internal punctum and punctal depth before treatment using AS-OCT, and then patients were re-evaluated after one month of treatment with preservative free methylprednisolone 5% eye drops.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients have acquired inflammatory punctum stenosis complaining of epiphora of different etiologies.

Exclusion criteria

• Previous lacrimal surgery.
• Lid margin malposition such as ectropion, entropion or lid retraction.
• Medial lid masses obscuring punctum.
• History of ocular trauma involving lid margin or punctum.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Methylprednisolone eye drops

Other group

Description:

Preservative free steroids methylprednisolone 5% eye drops (prepared by dilution of methyleprednisolone 500mg in 10 ml distilled water (Solu-Medrol, Pfizer company) was prepared and given for all enrolled cases by the following regimen 5 times/day for 5 days with gradual decrease every third day over the following 2 weeks

Treatment:

Drug: Methylprednisolone eyedrops

distilled water eyedrops

Placebo Comparator group

Description:

Distilled water eyedrops instilled 3 times per day for two weeks

Treatment:

Drug: Methylprednisolone eyedrops