Pterygium of Both EyesSICAGNCT07894848
Sutureless Suerior vs Inferior Conjunctival Autograft for Pterygium
A study testing Sutureless Superior Conjunctival Autograft (CAG) and Sutureless Inferior Conjunctival Autograft (CAG) in people with Pterygium of Both Eyes and Conjunctival Autograft, run by Fayoum University at 1 site in Egypt.
Trial summary
Superior bulbar conjunctival autograft is the standard procedure to reduce recurrence after pterygium excision. However, harvesting superior conjunctiva causes tissue scarring, which may compromise the site for potential future glaucoma filtering surgeries. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Pterygium of Both Eyes, Conjunctival Autograft
- What is being tested?
- Sutureless Superior Conjunctival Autograft (CAG) and Sutureless Inferior Conjunctival Autograft (CAG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Apr 2025to 2 Mar 2026
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 30 years or older of any gender.
- Unilateral or bilateral primary active nasal or temporal pterygium requiring surgical excision.
- Patient willing and capable of adhering to the scheduled post-operative follow-up visits (1 day, 1 week, 1 month, 3 months, and 6 months).
- Provided signed, written informed consent prior to enrollment.
Who cannot join
- Recurrent pterygium or pseudopterygium.
- Presence of cicatrizing ocular surface diseases (e.g., ocular cicatricial pemphigoid, Stevens-Johnson syndrome, chemical burns, or ocular trauma).
- Pre-existing glaucoma, ocular hypertension, or history of previous conjunctival surgery in the study eye.
- Active ocular infection, severe blepharitis, or dry eye syndrome.
- Known allergy or hypersensitivity to local anesthetics, fluoroquinolones, or topical steroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Sutureless Superior and Inferior Conjunctival Autograft in Treatment of Pterygium.
Superior bulbar conjunctival autograft is the standard procedure to reduce recurrence after pterygium excision. However, harvesting superior conjunctiva causes tissue scarring, which may compromise the site for potential future glaucoma filtering surgeries. This study evaluates whether harvesting a sutureless autograft from the inferior bulbar/forniceal conjunctiva provides comparable graft stability, pain levels, and recurrence rates while preserving the superior conjunctiva.
- Conditions
- Pterygium of Both Eyes, Conjunctival Autograft
- Being tested
- Sutureless Superior Conjunctival Autograft (CAG), Sutureless Inferior Conjunctival Autograft (CAG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sutureless Superior Conjunctival Autograft (CAG)Other
Also called conjunctival autograft
Following local anesthesia with topical proparacaine 0.5% and subconjunctival 2% lidocaine infiltration, standard surgical excision of the primary pterygium head and body is performed along with meticulous clearance of corneal and scleral bed fibrovascular tissue.
A thin, donor conjunctival autograft matching the dimensions of the bare scleral bed (measured via surgical calipers) is harvested from the superior limbal/bulbar conjunctiva, incorporating limbal stem cell tissue. The graft is transferred to the recipient site maintaining correct orientation (limbus-to-limbus).
Fixation is achieved suturelessly without the use of synthetic sutures. Pressure is applied over the graft for 5 to 10 minutes to ensure firm apposition prior to monocular eye patching.
Sutureless Inferior Conjunctival Autograft (CAG)Other
Following local anesthesia with topical proparacaine 0.5% and subconjunctival 2% lidocaine infiltration, standard surgical excision of the primary pterygium head and body is performed along with meticulous clearance of corneal and scleral bed fibrovascular tissue.
A thin, donor conjunctival autograft matching the dimensions of the bare scleral bed (measured via surgical calipers) is harvested from the infronasal / inferior bulbar and forniceal conjunctiva, deliberately sparing the entire superior bulbar conjunctiva for potential future ocular surgeries. The graft is transferred to the recipient site maintaining correct limbus-to-limbus orientation.
Fixation is achieved suturelessly without the use of synthetic sutures. Pressure is applied over the graft for 5 to 10 minutes to ensure firm apposition prior to monocular eye patching.
| Study group | Role | What they receive |
|---|---|---|
| superior conjunctival autograft | Active comparator | Pterygium excision followed by preparation and placement of a sutureless autograft harvested from the superior limbal/bulbar conjunctiva. Receives: Other: Sutureless Superior Conjunctival Autograft (CAG) |
| inferior conjunctival autograft | Experimental | Pterygium excision followed by preparation and placement of a sutureless autograft harvested from the infronasal/inferior bulbar conjunctiva. Receives: Other: Sutureless Inferior Conjunctival Autograft (CAG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pterygium Recurrence Rate
Presence of fibrovascular tissue regrowth crossing the corneo-limbal junction onto the clear cornea .
Measured: Evaluated at 6 months postoperatively
Graft Stability and Adherence
Evaluated on slit-lamp examination as stable, partially displaced, fully displaced, retracted, or lost.
Measured: Evaluated on Day 1, Week 1, Month 1, Month 3, and Month 6
Secondary outcomes (3)
Postoperative Pain Levels
Patient self-reported pain score assessed on a standardized 10-point Visual Analog Scale (VAS) (0 = No Pain, 10 = Worst Possible Pain).
Measured: Day 1, Week 1, and Month 1 postoperatively
operative time
time spent at surgery from local anaesthesia injection to graft placement
Measured: at surgery
donor site healing
evaluated on slit lamp as time needed for the donor site to achieve complete healing
Measured: Day 1, Week 1, and Month 1 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start27 Apr 2025
- Primary completion8 Jan 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pterygium of Both EyesStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Abdul Fattah Saad, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894848
- Sponsor's protocol ID
- R910
- Acronym
- SICAG
- Status last verified
- Apr 2025
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Sutureless Superior and Inferior Conjunctival Autograft in Treatment of Pterygium.
- ClinicalTrials.gov ID
- NCT07894848
- Acronym / sponsor ID
- SICAG / R910
- Conditions
- Pterygium of Both Eyes, Conjunctival Autograft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 27 Apr 2025 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 26 Oct 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.
Superior bulbar conjunctival autograft is the standard procedure to reduce recurrence after pterygium excision. However, harvesting superior conjunctiva causes tissue scarring, which may compromise the site for potential future glaucoma filtering surgeries. This study evaluates whether harvesting a sutureless autograft from the inferior bulbar/forniceal conjunctiva provides comparable graft stability, pain levels, and recurrence rates while preserving the superior conjunctiva.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| superior conjunctival autograft | Active comparator | Other: Sutureless Superior Conjunctival Autograft (CAG)Pterygium excision followed by preparation and placement of a sutureless autograft harvested from the superior limbal/bulbar conjunctiva. |
| inferior conjunctival autograft | Experimental | Other: Sutureless Inferior Conjunctival Autograft (CAG)Pterygium excision followed by preparation and placement of a sutureless autograft harvested from the infronasal/inferior bulbar conjunctiva. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 30 years or older of any gender.
- Unilateral or bilateral primary active nasal or temporal pterygium requiring surgical excision.
- Patient willing and capable of adhering to the scheduled post-operative follow-up visits (1 day, 1 week, 1 month, 3 months, and 6 months).
- Provided signed, written informed consent prior to enrollment.
Key exclusion criteria (5 listed)
- Recurrent pterygium or pseudopterygium.
- Presence of cicatrizing ocular surface diseases (e.g., ocular cicatricial pemphigoid, Stevens-Johnson syndrome, chemical burns, or ocular trauma).
- Pre-existing glaucoma, ocular hypertension, or history of previous conjunctival surgery in the study eye.
- Active ocular infection, severe blepharitis, or dry eye syndrome.
- Known allergy or hypersensitivity to local anesthetics, fluoroquinolones, or topical steroids.
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 |
|---|---|---|
| Sutureless Superior Conjunctival Autograft (CAG)Also: conjunctival autograftFollowing local anesthesia with topical proparacaine 0.5% and subconjunctival 2% lidocaine infiltration, standard surgical excision of the primary pterygium head and body is performed along with meticulous clearance of corneal and scleral bed fibrovascular tissue. A thin, donor conjunctival autograft matching the dimensions of the bare scleral bed (measured via surgical calipers) is harvested from the superior limbal/bulbar conjunctiva, incorporating limbal stem cell tissue. The graft is transferred to the recipient site maintaining correct orientation (limbus-to-limbus). Fixation is achieved suturelessly without the use of synthetic sutures. Pressure is applied over the graft for 5 to 10 minutes to ensure firm apposition prior to monocular eye patching. | Other | superior conjunctival autograft |
| Sutureless Inferior Conjunctival Autograft (CAG)Following local anesthesia with topical proparacaine 0.5% and subconjunctival 2% lidocaine infiltration, standard surgical excision of the primary pterygium head and body is performed along with meticulous clearance of corneal and scleral bed fibrovascular tissue. A thin, donor conjunctival autograft matching the dimensions of the bare scleral bed (measured via surgical calipers) is harvested from the infronasal / inferior bulbar and forniceal conjunctiva, deliberately sparing the entire superior bulbar conjunctiva for potential future ocular surgeries. The graft is transferred to the recipient site maintaining correct limbus-to-limbus orientation. Fixation is achieved suturelessly without the use of synthetic sutures. Pressure is applied over the graft for 5 to 10 minutes to ensure firm apposition prior to monocular eye patching. | Other | inferior conjunctival autograft |
Primary outcome
Pterygium Recurrence Rate
Time frame: Evaluated at 6 months postoperatively
Presence of fibrovascular tissue regrowth crossing the corneo-limbal junction onto the clear cornea .
Graft Stability and Adherence
Time frame: Evaluated on Day 1, Week 1, Month 1, Month 3, and Month 6
Evaluated on slit-lamp examination as stable, partially displaced, fully displaced, retracted, or lost.
3 secondary outcomes
Postoperative Pain Levels
Time frame: Day 1, Week 1, and Month 1 postoperatively
operative time
Time frame: at surgery
donor site healing
Time frame: Day 1, Week 1, and Month 1 postoperatively
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 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Pterygium of Both Eyes
Not yet recruiting
Clinical Outcomes of Sutured Versus Sutureless Conjunctival Autograft in Primary Pterygium Excision
Pterygium of Conjunctiva and Cornea, Pterygium of Both Eyes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sutureless Superior Conjunctival Autograft (CAG) and Sutureless Inferior Conjunctival Autograft (CAG) in people with Pterygium of Both Eyes and Conjunctival Autograft, run by Fayoum University at 1 site in Egypt.
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 5 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pterygium Recurrence Rate (time frame: Evaluated at 6 months postoperatively). The study lists 2 primary outcomes in all. 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 26 Oct 2026.