Comparing two ways of preserving amniotic membrane for eye surgery

Characterization and systematization of the production of cryopreserved and lyophilized amniotic membrane for the treatment of Ocular Surface Diseases

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-5rps9h3

Enrollment

Registered

2026-07-07

Start date

2025-10-16

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pterygium of eye Conjunctival Diseases

Interventions

This is a two-arm, single-blind, randomized controlled clinical trial. Participant randomization will be performed using block randomization. Group A (cryopreserved amniotic membrane): 10 participants

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals over 18 years of age with ocular surface diseases, including chemical burns, Stevens-Johnson syndrome, pterygium, dry eye, and neurotrophic ulcer

Exclusion criteria

Exclusion criteria: Patient with an active ocular infection

Design outcomes

Primary

Measure	Time frame
To evaluate the non-inferiority of using freeze-dried amniotic membrane compared to cryopreserved amniotic membrane regarding the recurrence of primary nasal pterygium following Simple Limbal Epithelial Transplantation surgery. The outcome will be assessed through an ophthalmologic clinical evaluation to detect the return of pterygium growth following its surgical removal. To verify whether the outcome actually occurred, we will observe the recurrence rate (as a percentage) and the absolute number of patients who present with a relapse of the lesion at exactly 6 months of postoperative follow-up.	—

Measure

Time frame

To evaluate the non-inferiority of using freeze-dried amniotic membrane compared to cryopreserved amniotic membrane regarding the recurrence of primary nasal pterygium following Simple Limbal Epithelial Transplantation surgery. The outcome will be assessed through an ophthalmologic clinical evaluation to detect the return of pterygium growth following its surgical removal. To verify whether the outcome actually occurred, we will observe the recurrence rate (as a percentage) and the absolute number of patients who present with a relapse of the lesion at exactly 6 months of postoperative follow-up.

—

Secondary

Measure	Time frame
No secondary outcomes are expected.	—

Countries

Contacts

Public ContactMatheus Gasparini

Universidade Estadual de Campinas (Unicamp)

m262434@dac.unicamp.br+55(19) 3521-8002

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Aug 10, 2026