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Status unknownNCT03304366Updated Oct 9, 2017

Corneal Changes With Pentacam Before and After Pterygium

An observational study in Pterygium, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-09.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Aim of this study is to assess the corneal changes before and after pterygium excision by using pentacam system.

Read the detailed description

Pterygium is a dysplasia of the bulbar conjunctiva extending onto the corneal surface. The prevelance of pterygium ranges from 0.7% to 31% in various populations according to the location, altitude, and race. It has a higher prevelance in areas which have increased exposure to direct sun with ultraviolet (UV) B light. Patients with pterygia present with variety of complaints ,ranging from asymptomatic to significant redness ,swelling ,itching ,irritation and blurring of vision associated with elevated lesions of the conjunctiva and contiguous cornea in one or both eyes.The induction of astigmatism due to the invasion of the pterygium into the cornea as well as changes in corneal curvature and refractive status has been reported by numerous studies.

Multiple different procedures have been advocated in the treatment of pterygia. These procedures range from simple excision to sliding flaps of conjunctiva with or without adjunctive external beta radiation therapy and/or use of topical chemotherapeutic agents, such as Mitomycin C.

Pentacam is a rotating Scheimpflug camera which measures Scheimpflug images of the anterior eye segment. With the pentacam, topographic analysis of the corneal front and back surfaces is based on the true elevation measurement from one side of the cornea to the other (limbus to limbus). Pentacam also describes the true thickness of the cornea across its entire breadth and width.

Type of the study: prospective observational longitudinal study

Study Setting: Assuit University Hospital ( ophthalmology Department ) Assuit Police Hospital ( ophthalmology Department )

Study subjects:

  1. Inclusion criteria:

    • The study will include 30 eyes of adult subjects.
    • All eyes have primary pterygium and seeking for surgery due to Cosmetic problems, ocular irritation, and, or visual impairment.
    • All selected patients will undergo complete ophthalmological examination including refraction, best corrected visual acuity, keratometry, and pentacam (scheimpflug imaging) preoperatively then will be followed up 2 and 6 months post pterygium excision.

  2. Exclusion criteria:

    • patients with recurrent pterygium.

    • Patients with media opacities:

      • Dense cataract. - Corneal opacities.
    • Patients with a history of intraocular surgery ,ocular trauma ,and contact lens wear.
    • Patients with severe ocular surface disorders as Stevens-Johnson syndrome.
02

Conditions studied

  • Pterygium

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03

In context

Pterygium

109 studies on the registry are indexed under Pterygium; 9 are open to participants now.

This study's planned enrollment of 30 is below the median of 58 across 14 observational studies indexed under Pterygium.

Browse Pterygium studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Assiut University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with primary pterygium comes to Assiut University Hospital, Assiut Police Hospital, Private clinic They will perform the Pentacam analysis at Assuit Eye research centers (Alforsan-Elnoor)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All eyes have primary pterygium and seeking for surgery due to Cosmetic problems, ocular irritation, and, or visual impairment.
  • All selected patients will undergo complete ophthalmological examination including refraction, best corrected visual acuity, keratometry, and pentacam (scheimpflug imaging) preoperatively then will be followed up 2 and 6 months post pterygium excision.

Exclusion criteria

Exclusion Criteria:

  • patients with recurrent pterygium.
  • Patients with media opacities: Dense cataract, Corneal opacities.
  • Patients with a history of intraocular surgery ,ocular trauma ,and contact lens wear.
  • Patients with severe ocular surface disorders as Stevens-Johnson syndrome.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with primary pterygium

    * All eyes have primary pterygium and seeking for surgery due to Cosmetic problems, ocular irritation, and, or visual impairment. * All selected patients will undergo complete ophthalmological examination including refraction, best corrected visual acuity, keratometry, and pentacam (scheimpflug imaging) preoperatively then will be followed up 2 and 6 months post pterygium excision.

    Diagnostic Test: Pentacam (scheimpflug imaging)

Interventions

  • Diagnostic testPentacam (scheimpflug imaging)

    Corneal changes including thickness, elevations....etc

06

What researchers measure

Primary outcomes

  1. Pentacam analysis.

    Corneal changes such as thickness and elevations

    Time frame: preoperative and then will be followed up 2 and 6 months post pterygium excision.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — Sharing the results for other researchers

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2017; primary completion for Jan 2019, 14 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2017
First posted
Oct 9, 2017
StartEst.
Nov 2017
Primary completionEst.
Jan 2019
CompletionEst.
Jan 2019
Last update
Oct 9, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03304366
Lead sponsor
Assiut University
Responsible party
Mohamed Gamal (Resident Physician, Assiut University) — Principal investigator
First posted
Oct 9, 2017
Start date
Nov 2017 (estimated)
Primary completion
Jan 2019 (estimated)
Completion
Jan 2019 (estimated)
Last update
Oct 9, 2017

Study contacts

Mohammed G Abdelsalam, MBBCH
Contact
drmoh_gamal85@yahoo.com
01111188664 ext. 002
Mohammed S Abdelrahman, Prof
study chair · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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