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Amniotic Membrane Transplantation vs Conjunctival–Limbal Autograft for Primary Pterygium
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Amniotic Membrane Transplantation vs Conjunctival–Limbal Autograft , for Primary Pterygium. Randomized, blind controlled trial.
Secondary indentifying numbers:
SIDI 1483
Issuing authority of the secondary identifying numbers:
"Hermanos Ameijeiras" General Hospital.Research and Projects Department.
Primary sponsor:
"Hermanos Ameijeiras" General Hospital
Secondary sponsor:
CEADEN (Center for Technology Applications and Nuclear Development)
Source(s) of monetary or material support:
"Hermanos Ameijeiras" General Hospital CEADEN
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Only approved by Ethics Committees
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Belmary Aragonés Cruz
Last name:
Not entered
Affiliation:
Not entered
Postal address:
Not entered
City:
Not entered
País:
Not entered
Zip Code:
Not entered
Email address:
email@not.entered
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Research ethics committees:
“Hermanos Ameijeiras” General Hospital , September 4th 2006.
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Complete
Date of first enrollment:
17/09/2006
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Primary Pterygium
Intervention(s):
Group I: pterygium excision or pterigiectomy plus Amniotic Membrane Transplantation Group II: pterygium excision or pterigiectomy plus Conjunctival–Limbal Autograft
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Recurrence onset during first 6 months after surgery.
Key secondary outcomes:
Complications during first 6 months and one year after surgery. Difference between visual acuity before and after surgery (6 months and one year) Ametropy status compared with preoperative status (6 months and one year). Time to recurrence. Esthetic Appearance (6 months and one year).
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
15 years
Maximum age:
NA
Inclusion criteria:
Patients with primary pterigium grade II or higher. Cubans. Over 15 years of age.
Exclusion criteria:
With recurrent pterigium of any grade Previous corneal perforation or perforating trauma. Suspected conjunctival malignancy. Corneal leucoma. Any corneal inflammatory or degenerative disease. Background of allergy to topic steroids or Sjögren syndrome. If a patient presents pterigium in both eyes, only the worst eye will be included.
Type of population:
Children and Adults
Type of participant:
Patients
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Treatment
Allocation:
Randomized controlled trial
Masking:
Single Blind
Control group:
Active
Study design:
Parallel
Phase:
2-3
Target sample size:
221
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Belmary
Last Name:
Aragonés
Affiliation:
“Hermanos Ameijeiras” General Hospital
Postal Address:
San Lázaro 701 Centro Habana, 10300 Ciudad de La Habana
City:
Havana City
País:
Cuba
Zip Code:
10300
Telephone:
537 8761031
Email :
belmaryc@infomed.sld.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Rosa
Middle Name:
Eugenia
Last Name:
Jiménez
Affiliation:
“Hermanos Ameijeiras” General Hospital.
Postal Address:
San Lázaro 701 Centro Habana, 10300, Ciudad de La Habana.
City:
Havana City
País:
Cuba
Zip Code:
10300
Telephone:
8761626
Email :
rjimenez@infomed.sld.cu
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000081
Date of Registration in Primary Registry:
2009-07-03
Record Verification Date:
2009-06-30 20:00
Link to the spanish version:
Click here
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