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Proteomic Profiles in Trabeculectomy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01841580
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre

Brief Summary:

Approximately 70 million people world-wide are affected with glaucoma, of whom 6.7 million have bilateral blindness.5 Elevated intro-ocular pressure is the major modifiable risk factor in glaucoma, and reducing intraocular pressure to a consistently low level can delay disease progression and therefore, blindness.6 Topical intraocular pressure -lowering medication remains the first-line treatment for glaucoma, with surgical intervention playing a secondary role in cases suboptimally controlled with medication alone.

In this study, we plan to assess the change in tear proteins in trabeculectomy patients before and after operations. It is hoped that this study could help us gain more understanding of the possible mechanism accounting for the development of dry eye disease in glaucoma patients, which could help us develop better screening modalities and therapeutic agents for glaucoma patients at risk to prevent the development of dry eye disease.


Condition or disease
Glaucoma

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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-term Observation of Tear Proteomic Profiles and Ocular Surface in Trabeculectomy Patients Before and After Surgery
Study Start Date : November 2013
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma Tears




Primary Outcome Measures :
  1. Change from baseline in the tear protein profiles in trabeculectomy patients at 3 years [ Time Frame: Baseline and 3 years ]

Secondary Outcome Measures :
  1. Symptoms and severity of dry eye disease [ Time Frame: Baseline and 3 years ]
  2. Amount of tears will be measured [ Time Frame: Baseline and 3 years ]
  3. Tear Osmolarity will be measured [ Time Frame: Baseline and 3 years ]
  4. Tear meniscus height will be measured [ Time Frame: Baseline and 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
120 patients will be recruited for this study
Criteria

Inclusion Criteria:

  1. 120 patients will be recruited from glaucoma clinics in SNEC
  2. Patients age ≥ 21 years old
  3. Patients who require trabeculectomy operation

Information from the National Library of Medicine

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): NCT01841580


Locations
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Singapore
Singapore National Eye Centre/ Singapore Eye Research Institute
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
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Principal Investigator: Louis Tong, PhD Singapore National Eye Centre

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Responsible Party: Louis Tong, Clinician-Scientist, Senior Consultant, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT01841580    
Other Study ID Numbers: R980/89/2012
2013/020/A ( Other Identifier: Singhealth Centralised Institutional Review Board )
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Keywords provided by Louis Tong, Singapore National Eye Centre:
Tear proteins profiles
Longitudinal
Ocular surface damage
Trabeculectomy
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases