An interventional study of DCR in Acquired Nasolacrimal Duct Obstruction, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Minia University · Not applicable, Interventional, and Treatment
The aim of DCR is to form a new, mucosa-lined pathway between the lacrimal sac and the nasal cavity where tears can bypass a lacrimal obstruction and drain directly in the nose. The original external approach was described in 19046. In 1920s, mucosal flap anastomosis was added to the procedure as a modification7, and since then, many new modifications have been made to improve the original procedure.
Aim of The Study
Patients and Methods
Study Design: This will be a prospective interventional comparative clinical study. It will include two groups according to the surgical procedure:- Group A: includes 30 eyes that will be treated with external DCR with anastomosis of posterior mucosal flaps .
Group B: includes 30 eyes that will be treated with external DCR with amputation of posterior mucosal flaps .
Study Population:
Study participants will be: 60 eyes undergo external DCR . All patients included in this study will be verbally briefed about the details and the nature of the study \& will sign a written consent according to the local Ethics Committee of Minia University Faculty of Medicine. The study will be conducted in Ophthalmology department, Minia university Hospital, Egypt.
41 studies on the registry are indexed under Lacrimal Duct Obstruction; 8 are open to participants now.
This study's planned enrollment of 100 is above the median of 75 across 30 interventional studies indexed under Lacrimal Duct Obstruction.
Browse Lacrimal Duct Obstruction studies →Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Different techniques in posterior flap management
Other: DCR
6. An H shaped incision at the postero-inferior lacrimal sac is made, with a long anterior flap and shorter posterior flap. Similarly an H shaped incision at the nasal mucosa is made. The posterior flap of lacrimal sac is sutured with posterior flap of nasal mucosa in interrupted fashion using 6-0 vicryl sutures in Group A, while in Group B the posterior flap is trimmed without suturing.
Also known as: posterior flap management
Management of posterior flap in external DCR
Evaluation of different methods of posterior flaps management in external dacryocystorhinostomy using nasal endoscopy for evaluation of outcomes
Time frame: patient evaluated at 2 months after surgery then at 4th month then 6th month
Started Oct 2022 (actual). Primary completion is estimated for Oct 2024, 23 months after the start.
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