Conjunctival Transpositional Surgery for Primary Pterygium
Conjunctival Transpositional Pterygium Surgery: A Prospective Single-Arm Interventional Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Mohammed Arish, MD, FRCS
- Phone Number: 09151419155
- Email: mohammad.erish@zaums.ac.ir
Study Locations
-
-
Sistan and Balochistan
-
Zahedan, Sistan and Balochistan, Iran
- Recruiting
- Alzahra Eye Hospital, Zahedan University of Medical Sciences
-
Contact:
- Mohammed Arish, MD, FRCS
- Phone Number: 09151419155
- Email: mohammad.erish@zaums.ac.ir
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years or older
- Primary pterygium involving the cornea
- Ability to provide informed consent
Exclusion Criteria:
- Recurrent pterygium
- Previous ocular surface surgery
- Active ocular infection or inflammation
- Severe ocular surface disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Pterygium patients
|
A conjunctival incision was created at the upper and lower limbus to allow adequate tissue mobilization.
The pterygium tissue is dissected off the corneal surface without complete excision or creation of a bare sclera defect.
The fibrovascular tissue is mobilized and transposed inferiorly within the subconjunctival plane and secured with absorbable sutures.
Tenon's tissue is preserved, and no adjunctive therapy is used.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pterygium Recurrence
Time Frame: 12 months
|
Recurrence is defined as fibrovascular regrowth toward the cornea or surgical failure.
|
12 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Acuity
Time Frame: 12 months
|
Change in visual acuity measured in logMAR units.
|
12 months
|
|
Refractive Astigmatism
Time Frame: 12 months
|
Change in refractive astigmatism measured as cylindrical power in diopters.
|
12 months
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IR.ZAUMS.REC.1404.238
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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