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.

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 [1]

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:

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 [2]

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 [3]

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 [4]