Endoscopic Dacryocystorhinostomy Prospective Research
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ClinicalTrials.gov Identifier: NCT00571129 |
Recruitment Status
:
Active, not recruiting
First Posted
: December 11, 2007
Last Update Posted
: November 17, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lacrimal Duct Obstruction | Procedure: DCR | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Recovery After Endoscopic Dacryocystorhinostomy |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | December 2011 |
Estimated Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
---|---|
surgical |
Procedure: DCR
The patients were randomized into the two study groups, either with or without the insertion of a bicanalicular silicone tube after primary DCR. In revision group patients were randomized into the two groups,ether with or without application of mitomycin "C" after DCR |
- The success rate after primary DCR with and without silicone tubes. The success rate after revisio DCR with and without Mitomycin C. [ Time Frame: 5 years ]
- The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation. [ Time Frame: 5 years ]

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults (age > 18), ASAI-III, and were scheduled for primary or revision lacrimal pathway surgery due to recurrent or chronic watering eyes or conjunctival discharge.
- Patients were excluded if they had previous nasolacrimal surgery, malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.
Exclusion Criteria:
- Malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571129
Finland | |
Kuopio University Hospital | |
Kuopio, North-Savo, Finland, 70210 |
Study Chair: | Juha Seppä, MD,PhD | Institute of Clinical Medicine, Otorhinolaryngology, Kuopio University Hospital, and University of Kuopio, Finland |
Publications:
Responsible Party: | Juha Seppa, PhD, Kuopio University Hospital |
ClinicalTrials.gov Identifier: | NCT00571129 History of Changes |
Other Study ID Numbers: |
KUH5551812 255104 |
First Posted: | December 11, 2007 Key Record Dates |
Last Update Posted: | November 17, 2017 |
Last Verified: | November 2017 |
Keywords provided by Juha Seppa, Kuopio University Hospital:
Primary,silicone tube,revision,mitomycin C,endoscopic DCR |
Additional relevant MeSH terms:
Lacrimal Duct Obstruction Lacrimal Apparatus Diseases Eye Diseases |