PterygiumNCT05164900
Manifestations of Ocular Irritation Following Pterygium Excision With Sutures Fixed Conjunctival Autograft
A study testing pterygium excision with sutures fixed conjunctival auto-graft in people with Pterygium, run by Tanta University at 1 site in Egypt.
Trial summary
In this work, the manifestations of ocular irritation associated with vicryl 8/0 sutures fixed conjunctival auto-graft in pterygium patients were evaluated. The severity of post-operative foreign body sensation, pain, and watering was subjectively evaluated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pterygium
- What is being tested?
- pterygium excision with sutures fixed conjunctival auto-graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 1 Oct 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with pterygium
Who cannot join
- Previous ocular surgeries
- Ocular surface disorders
Trial locations and contacts
1 site in 1 country.
About this study
In this work, the manifestations of ocular irritation associated with vicryl 8/0 sutures fixed conjunctival auto-graft in pterygium patients were evaluated. The severity of post-operative foreign body sensation, pain, and watering was subjectively evaluated. The localized nasal quadrant conjunctival hyperemia was also evaluated. It was found that sutures fixed conjunctival auto-graft can be used safely with short-term minimal to moderate tolerable manifestations of ocular irritation with no significant complications.
Read the detailed description
All the patients were subjected to pterygium excision surgery with conjunctival auto-graft under local anesthesia. The graft was fixed by vicryl 8-0 sutures.Ocular irritation symptoms including pain, foreign body sensation and watering were subjectively evaluated. Pain was evaluated using 5 points scale, where (0) indicated no pain; (1) very mild easily tolerable pain; (2) mild pain with discomfort; (3) moderate pain that interfered with the usual activities; (4) severe pain that totally interfered with performing daily activities or sleep. Foreign body sensation and watering of the eye were evaluated with the use of a 4 points abnormal sensation scale, where (0) indicated no abnormal sensation; (1) is somewhat bothersome; (2) is moderately bothersome; (3) is very bothersome. The score of patients' subjective symptoms evaluation were collected in a total score which ranged from zero to a maximum of 10. A total score of 3 or less was considered as minimal irritation (grade I), 4-6 was considered as mild-moderate tolerable irritation (grade II), and 7 or more was considered as severe annoying irritation (grade III).
The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated 2 weeks, 1,2 and 3 months post-operative using the Cornea and Contact Lens Research Unit (CCLRU) photographic grading scale. In this scale 1 refers to very slight; 2 slight; 3 moderate; 4 severe. Decimal fraction of 0.5 was added to describe the intermediate cases.
- Conditions
- Pterygium
- Being tested
- pterygium excision with sutures fixed conjunctival auto-graft
- Keywords
- pterygium excision, conjunctival auto-graft, ocular irritation, conjunctival hyperemia
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pterygium excision with sutures fixed conjunctival auto-graftProcedure or surgery
Pterygium excision with vicryl 8/0 fixed conjunctival auto-graft under local anesthesia. During the follow up period, indicators of ocular irritation were assessed.
| Study group | Role | What they receive |
|---|---|---|
| patients with nasal pterygium. | Experimental | Not described Receives: Procedure: pterygium excision with sutures fixed conjunctival auto-graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular pain was subjectively evaluated.
The pain was evaluated using 5 points scale, where (0) indicated no pain; (1) very mild easily tolerable pain; (2) mild pain with discomfort; (3) moderate pain that interfered with the usual activities; (4) severe pain that totally interfered with performing daily activities or sleep.
Measured: 1 week after surgery.
Change of ocular pain subjective evaluation.
The pain was evaluated using 5 points scale, where (0) indicated no pain; (1) very mild easily tolerable pain; (2) mild pain with discomfort; (3) moderate pain that interfered with the usual activities; (4) severe pain that totally interfered with performing daily activities or sleep.
Measured: 2 weeks, 1 month, 2 and 3 months post-operative.
Ocular foreign body sensation was subjectively evaluated.
Foreign body sensation was evaluated with the use of a 4 points abnormal sensation scale, where (0) indicated no abnormal sensation; (1) is somewhat bothersome; (2) is moderately bothersome; (3) is very bothersome.
Measured: 1 week after surgery.
Change of ocular foreign body sensation subjective evaluation.
Foreign body sensation was evaluated with the use of a 4 points abnormal sensation scale, where (0) indicated no abnormal sensation; (1) is somewhat bothersome; (2) is moderately bothersome; (3) is very bothersome.
Measured: 2 weeks, 1 month, 2 and 3 months post-operative.
Watering of the eye was subjectively evaluated.
Watering of the eye was evaluated with the use of a 4 points abnormal sensation scale, where (0) indicated no abnormal sensation; (1) is somewhat bothersome; (2) is moderately bothersome; (3) is very bothersome.
Measured: 1 week after surgery.
Change of watering of the eye subjective evaluation.
Watering of the eye was evaluated with the use of a 4 points abnormal sensation scale, where (0) indicated no abnormal sensation; (1) is somewhat bothersome; (2) is moderately bothersome; (3) is very bothersome.
Measured: 2 weeks, 1 month, 2 and 3 months post-operative.
The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated.
The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated using the cornea and contact lens research unit (CCLRU) photographic grading scale. In this scale 1 refers to very slight; 2 slight; 3 moderate; 4 severe.
Measured: 2 weeks after surgery.
Change of the degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated.
The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated using the cornea and contact lens research unit (CCLRU) photographic grading scale. In this scale 1 refers to very slight; 2 slight; 3 moderate; 4 severe.
Measured: 1month,2 and 3 months post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Jul 2020
- Primary completion1 Apr 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Molham Abdelhafez Elbakary, Tanta University
- Investigators
- Molham Elbakary, Principal investigator, Assitant professor of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164900
- Sponsor's protocol ID
- 34970/10/21
- Status last verified
- Dec 2021
- First submitted
- 4 Dec 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manifestations of Ocular Irritation Following Pterygium Excision With Sutures Fixed Conjunctival Autograft
- ClinicalTrials.gov ID
- NCT05164900
- Acronym / sponsor ID
- 34970/10/21
- Conditions
- Pterygium
- Keywords
- pterygium excision, conjunctival auto-graft, ocular irritation, conjunctival hyperemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 21 Dec 2021 (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.
In this work, the manifestations of ocular irritation associated with vicryl 8/0 sutures fixed conjunctival auto-graft in pterygium patients were evaluated. The severity of post-operative foreign body sensation, pain, and watering was subjectively evaluated. The localized nasal quadrant conjunctival hyperemia was also evaluated. It was found that sutures fixed conjunctival auto-graft can be used safely with short-term minimal to moderate tolerable manifestations of ocular irritation with no significant complications.
Detailed description
All the patients were subjected to pterygium excision surgery with conjunctival auto-graft under local anesthesia. The graft was fixed by vicryl 8-0 sutures.Ocular irritation symptoms including pain, foreign body sensation and watering were subjectively evaluated. Pain was evaluated using 5 points scale, where (0) indicated no pain; (1) very mild easily tolerable pain; (2) mild pain with discomfort; (3) moderate pain that interfered with the usual activities; (4) severe pain that totally interfered with performing daily activities or sleep. Foreign body sensation and watering of the eye were evaluated with the use of a 4 points abnormal sensation scale, where (0) indicated no abnormal sensation; (1) is somewhat bothersome; (2) is moderately bothersome; (3) is very bothersome. The score of patients' subjective symptoms evaluation were collected in a total score which ranged from zero to a maximum of 10. A total score of 3 or less was considered as minimal irritation (grade I), 4-6 was considered as mild-moderate tolerable irritation (grade II), and 7 or more was considered as severe annoying irritation (grade III).
The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated 2 weeks, 1,2 and 3 months post-operative using the Cornea and Contact Lens Research Unit (CCLRU) photographic grading scale. In this scale 1 refers to very slight; 2 slight; 3 moderate; 4 severe. Decimal fraction of 0.5 was added to describe the intermediate cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with nasal pterygium. | Experimental | Procedure: pterygium excision with sutures fixed conjunctival auto-graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with pterygium
Key exclusion criteria (2 listed)
- Previous ocular surgeries
- Ocular surface disorders
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 |
|---|---|---|
| pterygium excision with sutures fixed conjunctival auto-graftPterygium excision with vicryl 8/0 fixed conjunctival auto-graft under local anesthesia. During the follow up period, indicators of ocular irritation were assessed. | Procedure or surgery | patients with nasal pterygium. |
Primary outcome
Ocular pain was subjectively evaluated.
Time frame: 1 week after surgery.
The pain was evaluated using 5 points scale, where (0) indicated no pain; (1) very mild easily tolerable pain; (2) mild pain with discomfort; (3) moderate pain that interfered with the usual activities; (4) severe pain that totally interfered with performing daily activities or sleep.
Change of ocular pain subjective evaluation.
Time frame: 2 weeks, 1 month, 2 and 3 months post-operative.
The pain was evaluated using 5 points scale, where (0) indicated no pain; (1) very mild easily tolerable pain; (2) mild pain with discomfort; (3) moderate pain that interfered with the usual activities; (4) severe pain that totally interfered with performing daily activities or sleep.
Ocular foreign body sensation was subjectively evaluated.
Time frame: 1 week after surgery.
Foreign body sensation was evaluated with the use of a 4 points abnormal sensation scale, where (0) indicated no abnormal sensation; (1) is somewhat bothersome; (2) is moderately bothersome; (3) is very bothersome.
Change of ocular foreign body sensation subjective evaluation.
Time frame: 2 weeks, 1 month, 2 and 3 months post-operative.
Foreign body sensation was evaluated with the use of a 4 points abnormal sensation scale, where (0) indicated no abnormal sensation; (1) is somewhat bothersome; (2) is moderately bothersome; (3) is very bothersome.
Watering of the eye was subjectively evaluated.
Time frame: 1 week after surgery.
Watering of the eye was evaluated with the use of a 4 points abnormal sensation scale, where (0) indicated no abnormal sensation; (1) is somewhat bothersome; (2) is moderately bothersome; (3) is very bothersome.
Change of watering of the eye subjective evaluation.
Time frame: 2 weeks, 1 month, 2 and 3 months post-operative.
Watering of the eye was evaluated with the use of a 4 points abnormal sensation scale, where (0) indicated no abnormal sensation; (1) is somewhat bothersome; (2) is moderately bothersome; (3) is very bothersome.
The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated.
Time frame: 2 weeks after surgery.
The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated using the cornea and contact lens research unit (CCLRU) photographic grading scale. In this scale 1 refers to very slight; 2 slight; 3 moderate; 4 severe.
Change of the degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated.
Time frame: 1month,2 and 3 months post-operative.
The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated using the cornea and contact lens research unit (CCLRU) photographic grading scale. In this scale 1 refers to very slight; 2 slight; 3 moderate; 4 severe.
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 21 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Molham Elbakary principal investigator
Assitant professor of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pterygium excision with sutures fixed conjunctival auto-graft in people with Pterygium, run by Tanta 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 1 inclusion and 2 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 21 Dec 2021. 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?
Ocular pain was subjectively evaluated. (time frame: 1 week after surgery.). The study lists 8 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 21 Dec 2021.