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Double conjunctival flap with suture versus conjunctival autograft with glue for primary pterygium: a prospective, randomized study

Conjunctival autotransplantation with glue versus double flap with suture for primary pterygium. Interventional study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-3s85fz4
Enrollment
Unknown
Registered
2025-11-05
Start date
2025-11-20
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Pterygium

Interventions

A two-arm, randomized controlled clinical trial will be conducted. The study group will include 80 eyes from 80 patients, screened at the ophthalmology outpatient clinic of the Universidade Federal do
upon finding a cleavage plane between the head of the pterygium and the cornea, the pterygium will be dissected towards its body using Westcott scissors, also removing the subconjunctival fibrovascula
avulsion&quot
or blunt dissection of the pterygium head from the cornea will be performed. With a No. 15 scalpel blade

Sponsors

Hospital Universitário da Universidade Federal do Maranhão/HU/UFMA
Lead Sponsor
Hospital Universitário da Universidade Federal do Maranhão/HU/UFMA
Collaborator

Eligibility

Age
18 Years to 81 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria will be patients aged over 18 and under 80 years; without the occurrence of ocular surface disease, including dry eye and blepharitis, and with availability for clinical follow-up for at least six months after surgery. This information will be collected during ophthalmological consultations. To eliminate duplication bias when using both eyes from the same patient, only the first operated eye will be included in the analysis.

Exclusion criteria

Exclusion criteria: Exclusion criteria will include patients under 18 or over 80 years of age; presence of symblepharon; cicatricial conjunctival diseases; glaucoma; ocular allergy; recurrent pterygium in the ipsilateral eye, and those who do not sign the Free and Informed Consent Form.

Design outcomes

Primary

MeasureTime frame
It is expected not to find a statistically significant difference in treatment efficacy when comparing conjunctival autograft versus double conjunctival flap rotation for the treatment of primary pterygium.

Secondary

MeasureTime frame
To evaluate if there is a statistically significant difference between the groups when comparing recurrence, cosmetic aspects, and postoperative complications between the two techniques.

Countries

Brazil

Contacts

Public ContactPlinio Leal

Hospital Universitário da Universidade Federal do Maranhão/HU/UFMA

pliniocunhaleal@hotmail.com+55 (98) 98852-2021

Outcome results

None listed

Source: REBEC (via WHO ICTRP)