Primary PterygiumRETOPNCT07742995
Preoperative and Postoperative Refractive and Topographic Evaluation in Patients With Primary Pterygium: Comparison of Two Surgical Techniques
An observational study of Primary Pterygium and Astigmatism, run by Instituto de Oftalmología Fundación Conde de Valenciana.
Trial summary
This study evaluated changes in refractive status and corneal topography before and after surgical treatment of primary pterygium. Patients undergoing pterygium excision were treated with either conjunctival autograft or amniotic membrane transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Pterygium, Astigmatism
- What is being tested?
- Conjunctival Autograft and Amniotic Membrane Transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2013to 1 Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with primary nasal pterygium who underwent pterygium excision with either conjunctival autograft (CAG) or amniotic membrane transplantation (AMT) at the Institute of Ophthalmology "Fundación Conde de Valenciana," Mexico City, Mexico, between April 2013 and March 2015. Eligible patients were identified from institutional clinical records according to the predefined inclusion and exclusion criteria. The surgical technique had been selected according to the treating surgeon's clinical judgment and was not assigned as part of the study.
Who may be able to join
- Adults aged 18 years or older.
- Diagnosis of primary nasal pterygium in one or both eyes.
- Pterygium extending at least 1 mm onto the cornea.
- Underwent primary pterygium excision with either conjunctival autograft (CAG) or amniotic membrane transplantation (AMT).
Who cannot join
- Corneal scars.
- Corneal ectatic disorders.
- History of ocular trauma.
- Previous ocular surgery.
- Cicatrizing ocular surface disease.
- Cataract or any other ocular condition that could affect visual function.
About this study
Official title: Preoperative and Postoperative Refractive and Topographic Evaluation in Patients With Primary Pterygium: A Comparison of Conjunctival Autograft and Amniotic Membrane Transplantation
This study evaluated changes in refractive status and corneal topography before and after surgical treatment of primary pterygium. Patients undergoing pterygium excision were treated with either conjunctival autograft or amniotic membrane transplantation. Visual acuity, refractive error, and corneal topographic parameters were assessed before surgery and after postoperative follow-up to compare the effectiveness of both surgical techniques in restoring corneal optics and improving visual outcomes.
Read the detailed description
Primary pterygium is a fibrovascular proliferation of the bulbar conjunctiva that extends onto the cornea and may induce significant refractive and topographic changes, resulting in visual impairment. Surgical excision is the treatment of choice for progressive lesions, with conjunctival autograft (CA) and amniotic membrane transplantation (AMT) representing two widely used techniques.
Patients underwent conjunctival autograft or amniotic membrane transplantation based solely on the treating surgeon's clinical judgment, independently of study participation. The study did not assign surgical interventions. Patients were prospectively followed to compare refractive and corneal topographic outcomes between the two naturally occurring treatment cohorts.
The primary objective was to compare postoperative refractive and topographic changes between the two surgical techniques. Secondary objectives included evaluating changes in visual acuity, corneal curvature, refractive astigmatism, topographic astigmatism, and identifying clinical factors associated with postoperative outcomes.
- Conditions
- Primary Pterygium, Astigmatism
- Being tested
- Conjunctival Autograft, Amniotic Membrane Transplantation
- Keywords
- Primary Pterygium, Conjunctival Autograft, Amniotic Membrane Transplantation, Corneal Topography
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjunctival AutograftProcedure or surgery
Surgical excision of primary pterygium followed by transplantation of an autologous superior temporal conjunctival graft to cover the bare scleral bed.
Amniotic Membrane TransplantationProcedure or surgery
Surgical excision of primary pterygium followed by placement of preserved amniotic membrane over the bare scleral bed.
| Study group | Role | What they receive |
|---|---|---|
| Conjunctival Autograft | Participants with primary pterygium underwent pterygium excision followed by conjunctival autograft transplantation. Postoperative refractive status, visual acuity, and corneal topographic outcomes were evaluated during a 12-month follow-up. Receives: Procedure: Conjunctival Autograft | |
| Amniotic Membrane Transplantation | Participants with primary pterygium underwent pterygium excision followed by amniotic membrane transplantation. Postoperative refractive status, visual acuity, and corneal topographic outcomes were evaluated during a 12-month follow-up. Receives: Procedure: Amniotic Membrane Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Corneal Topographic Astigmatism
Comparison of the change in corneal topographic astigmatism from baseline to 12 months after pterygium excision between conjunctival autograft and amniotic membrane transplantation.
Measured: Baseline and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Apr 2013
- Primary completion1 Mar 2015
- Study completion1 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary PterygiumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742995
- Sponsor's protocol ID
- PTERYG-AC-TMA
- Acronym
- RETOP
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative and Postoperative Refractive and Topographic Evaluation in Patients With Primary Pterygium: A Comparison of Conjunctival Autograft and Amniotic Membrane Transplantation
- ClinicalTrials.gov ID
- NCT07742995
- Acronym / sponsor ID
- RETOP / PTERYG-AC-TMA
- Conditions
- Primary Pterygium, Astigmatism
- Keywords
- Primary Pterygium, Conjunctival Autograft, Amniotic Membrane Transplantation, Corneal Topography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 1 Mar 2015 (actual)
- Study completion
- 1 Mar 2015 (actual)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated changes in refractive status and corneal topography before and after surgical treatment of primary pterygium. Patients undergoing pterygium excision were treated with either conjunctival autograft or amniotic membrane transplantation. Visual acuity, refractive error, and corneal topographic parameters were assessed before surgery and after postoperative follow-up to compare the effectiveness of both surgical techniques in restoring corneal optics and improving visual outcomes.
Detailed description
Primary pterygium is a fibrovascular proliferation of the bulbar conjunctiva that extends onto the cornea and may induce significant refractive and topographic changes, resulting in visual impairment. Surgical excision is the treatment of choice for progressive lesions, with conjunctival autograft (CA) and amniotic membrane transplantation (AMT) representing two widely used techniques.
Patients underwent conjunctival autograft or amniotic membrane transplantation based solely on the treating surgeon's clinical judgment, independently of study participation. The study did not assign surgical interventions. Patients were prospectively followed to compare refractive and corneal topographic outcomes between the two naturally occurring treatment cohorts.
The primary objective was to compare postoperative refractive and topographic changes between the two surgical techniques. Secondary objectives included evaluating changes in visual acuity, corneal curvature, refractive astigmatism, topographic astigmatism, and identifying clinical factors associated with postoperative outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conjunctival Autograft | – | Procedure: Conjunctival AutograftParticipants with primary pterygium underwent pterygium excision followed by conjunctival autograft transplantation. Postoperative refractive status, visual acuity, and corneal topographic outcomes were evaluated during a 12-month follow-up. |
| Amniotic Membrane Transplantation | – | Procedure: Amniotic Membrane TransplantationParticipants with primary pterygium underwent pterygium excision followed by amniotic membrane transplantation. Postoperative refractive status, visual acuity, and corneal topographic outcomes were evaluated during a 12-month follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with primary nasal pterygium who underwent pterygium excision with either conjunctival autograft (CAG) or amniotic membrane transplantation (AMT) at the Institute of Ophthalmology "Fundación Conde de Valenciana," Mexico City, Mexico, between April 2013 and March 2015. Eligible patients were identified from institutional clinical records according to the predefined inclusion and exclusion criteria. The surgical technique had been selected according to the treating surgeon's clinical judgment and was not assigned as part of the study.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Diagnosis of primary nasal pterygium in one or both eyes.
- Pterygium extending at least 1 mm onto the cornea.
- Underwent primary pterygium excision with either conjunctival autograft (CAG) or amniotic membrane transplantation (AMT).
Key exclusion criteria (6 listed)
- Corneal scars.
- Corneal ectatic disorders.
- History of ocular trauma.
- Previous ocular surgery.
- Cicatrizing ocular surface disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conjunctival AutograftSurgical excision of primary pterygium followed by transplantation of an autologous superior temporal conjunctival graft to cover the bare scleral bed. | Procedure or surgery | Conjunctival Autograft |
| Amniotic Membrane TransplantationSurgical excision of primary pterygium followed by placement of preserved amniotic membrane over the bare scleral bed. | Procedure or surgery | Amniotic Membrane Transplantation |
Primary outcome
Change in Corneal Topographic Astigmatism
Time frame: Baseline and 12 months after surgery
Comparison of the change in corneal topographic astigmatism from baseline to 12 months after pterygium excision between conjunctival autograft and amniotic membrane transplantation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Pterygium and Astigmatism, run by Instituto de Oftalmología Fundación Conde de Valenciana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Corneal Topographic Astigmatism (time frame: Baseline and 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.