Cataract; ComplicataNCT04333069
Outcome of Cataract Surgery With Uveitis
A study testing cataract surgery in people with Cataract; Complicata, run by Assiut University.
Trial summary
Aim of the study is to evaluate outcome of cataract surgery in different types of uveitis as regarding best corrected visual acuity (BCVA) and rate of post operative complications. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Cataract; Complicata
- What is being tested?
- cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2020to 20 Dec 2022
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Visually significant cataract ( means opacification of the crystalline lens adequate to interfere with vision)in patients with uveitis controlled for at least 1month.
Who cannot join
- Irreversible pathology affecting outcome e.g. macular scar ,optic atrophy, and retinal detachment.
- Patients with active uveitis (means inflammation inside the eye).
- Patients less than 16 years old.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outcome of Cataract Surgery in Patient With Uveitis
Aim of the study is to evaluate outcome of cataract surgery in different types of uveitis as regarding best corrected visual acuity (BCVA) and rate of post operative complications.
Read the detailed description
Cataract is the main cause of reversible blindness in patients with uveitis. Cataract occurs in up to 50% to 70% of patients with uveitis.
Preoperative complications, including anterior synechiae, posterior synechiae, and pupillary membrane formation, may increase surgical challenges. In addition, recurrent inflammation increases the incidence of postoperative complications and often affects the visual prognosis. In recent years, phacoemulsification with intra ocular lens (IOL)implantation has become the main surgical method for treating uveitis (complicated cataract), and the visual prognosis of patients who undergo this procedure is usually favorable.
Surgical treatment may be effective but is associated with higher rates of complication than in non uveitic eyes. Cystoid macular edema (CME) is the most common complication cataract surgery in the general population. Although, in most cases, the macular edema is self-limited, in rare cases it can lead to long-term visual deterioration that is difficult to treat.
Another common complication after cataract surgery is posterior capsule opacification (PCO) , leading to symptoms of glare or blurred vision, reduced visual acuity, or impaired posterior segment exam. Factors that are critical in the development of PCO include surgical technique, type of implanted intra ocular lens (IOL) either foldable hydrophilic acrylic, hydrophobic acrylic or silicone and postoperative control of uveitis
- Conditions
- Cataract; Complicata
- Being tested
- cataract surgery
- Keywords
- uveitis
- Medical subject headings
- Cataract, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
cataract surgery in form of phaco emulsification or irrigation aspiration
| Study group | Role | What they receive |
|---|---|---|
| Uncorrected and best corrected visual acuity | Other | Measuring of uncorrected and best corrected visual acuity after phaco emulsification and irrigation aspiration cataract surgery Receives: Procedure: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
final postoperative uncorrected visual acuity (UCVA)
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
Measured: 1 week post operative
final postoperative uncorrected visual acuity (UCVA)
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
Measured: 1month post operative
final postoperative uncorrected visual acuity (UCVA)
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
Measured: 3months post operative
final postoperative uncorrected visual acuity (UCVA)
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
Measured: 6months post operative
Final post operative best corrected visual acuity (BCVA)
Post operative visual acuity with spectacle correction
Measured: 1 week post operative
Final post operative best corrected visual acuity (BCVA)
Post operative visual acuity with spectacle correction
Measured: 1month post operative
Final post operative best corrected visual acuity (BCVA)
Post operative visual acuity with spectacle correction
Measured: 3months post operative
Final post operative best corrected visual acuity (BCVA)
Post operative visual acuity with spectacle correction
Measured: 6months post operative
Secondary outcomes (2)
incidence of postoperative complications
cystoid macular edema which mean inflammation, swelling and collection of fluid inside macula) .
Measured: 6 months post operative
Reactivation of intraocular inflammation
Appearance of inflammatory activity inside the eye after period of quiescence of at least 6 months
Measured: 6 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 posted3 Apr 2020
- Study start10 Apr 2020 (estimated)
- Primary completion20 May 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cataract; ComplicataStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Abdallah Abdal Razik Ahmed, Assiut University
- Investigators
- Ashraf Khalaf Al Husseini, professor, Study director, Assiut UniversityWael Mohammed Ahmed Soliman, professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333069
- Sponsor's protocol ID
- cat in uveitic patients
- Status last verified
- Mar 2020
- First submitted
- 28 Mar 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carpentier SJ, Jung JL, Patnaik JL, Pecen PE, Palestine AG. A Cross-Sectional Online Survey Identifies Subspecialty Differences in the Management of Pediatric Cataracts Associated with Uveitis. Ophthalmol Ther. 2020 Jun;9(2):293-303. doi: 10.1007/s40123-020-00245-x. Epub 2020 Mar 10.
PubMed 32157612Chen JL, Bhat P, Lobo-Chan AM. Perioperative Management of Uveitic Cataracts. Adv Ophthalmol Optom. 2019 Aug;4:325-339. doi: 10.1016/j.yaoo.2019.04.014. Epub 2019 May 18.
PubMed 31788579Yangzes S, Seth NG, Singh R, Gupta PC, Jinagal J, Pandav SS, Gupta V, Gupta A, Ram J. Long-term outcomes of cataract surgery in children with uveitis. Indian J Ophthalmol. 2019 Apr;67(4):490-495. doi: 10.4103/ijo.IJO_846_18.
PubMed 30900580Jinagal J, Gupta G, Agarwal A, Aggarwal K, Akella M, Gupta V, Suri D, Gupta A, Singh S, Ram J. Safety and efficacy of dexamethasone implant along with phacoemulsification and intraocular lens implantation in children with juvenile idiopathic arthritis associated uveitis. Indian J Ophthalmol. 2019 Jan;67(1):69-74. doi: 10.4103/ijo.IJO_713_18.
PubMed 30574896El Gharbawy SA, Darwish EA, Abu Eleinen KG, Osman MH. Efficacy of addition of nepafenac 0.1% to steroid eye drops in prevention of post-phaco macular edema in high-risk eyes. Eur J Ophthalmol. 2019 Jul;29(4):453-457. doi: 10.1177/1120672118799626. Epub 2018 Sep 11.
PubMed 30203671
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Cataract Surgery in Patient With Uveitis
- ClinicalTrials.gov ID
- NCT04333069
- Acronym / sponsor ID
- cat in uveitic patients
- Conditions
- Cataract; Complicata
- Keywords
- uveitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Apr 2020 (estimated)
- Primary completion
- 20 May 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 3 Apr 2020 (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.
Aim of the study is to evaluate outcome of cataract surgery in different types of uveitis as regarding best corrected visual acuity (BCVA) and rate of post operative complications.
Detailed description
Cataract is the main cause of reversible blindness in patients with uveitis. Cataract occurs in up to 50% to 70% of patients with uveitis.
Preoperative complications, including anterior synechiae, posterior synechiae, and pupillary membrane formation, may increase surgical challenges. In addition, recurrent inflammation increases the incidence of postoperative complications and often affects the visual prognosis. In recent years, phacoemulsification with intra ocular lens (IOL)implantation has become the main surgical method for treating uveitis (complicated cataract), and the visual prognosis of patients who undergo this procedure is usually favorable.
Surgical treatment may be effective but is associated with higher rates of complication than in non uveitic eyes. Cystoid macular edema (CME) is the most common complication cataract surgery in the general population. Although, in most cases, the macular edema is self-limited, in rare cases it can lead to long-term visual deterioration that is difficult to treat.
Another common complication after cataract surgery is posterior capsule opacification (PCO) , leading to symptoms of glare or blurred vision, reduced visual acuity, or impaired posterior segment exam. Factors that are critical in the development of PCO include surgical technique, type of implanted intra ocular lens (IOL) either foldable hydrophilic acrylic, hydrophobic acrylic or silicone and postoperative control of uveitis
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uncorrected and best corrected visual acuity | Other | Procedure: cataract surgeryMeasuring of uncorrected and best corrected visual acuity after phaco emulsification and irrigation aspiration cataract surgery |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Visually significant cataract ( means opacification of the crystalline lens adequate to interfere with vision)in patients with uveitis controlled for at least 1month.
Key exclusion criteria (3 listed)
- Irreversible pathology affecting outcome e.g. macular scar ,optic atrophy, and retinal detachment.
- Patients with active uveitis (means inflammation inside the eye).
- Patients less than 16 years old.
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 |
|---|---|---|
| cataract surgerycataract surgery in form of phaco emulsification or irrigation aspiration | Procedure or surgery | Uncorrected and best corrected visual acuity |
Primary outcome
final postoperative uncorrected visual acuity (UCVA)
Time frame: 1 week post operative
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
final postoperative uncorrected visual acuity (UCVA)
Time frame: 1month post operative
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
final postoperative uncorrected visual acuity (UCVA)
Time frame: 3months post operative
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
final postoperative uncorrected visual acuity (UCVA)
Time frame: 6months post operative
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
Final post operative best corrected visual acuity (BCVA)
Time frame: 1 week post operative
Post operative visual acuity with spectacle correction
Final post operative best corrected visual acuity (BCVA)
Time frame: 1month post operative
Post operative visual acuity with spectacle correction
Final post operative best corrected visual acuity (BCVA)
Time frame: 3months post operative
Post operative visual acuity with spectacle correction
Final post operative best corrected visual acuity (BCVA)
Time frame: 6months post operative
Post operative visual acuity with spectacle correction
2 secondary outcomes
incidence of postoperative complications
Time frame: 6 months post operative
Reactivation of intraocular inflammation
Time frame: 6 months post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Background: PubMed 32157612Carpentier SJ, Jung JL, Patnaik JL, Pecen PE, Palestine AG. A Cross-Sectional Online Survey Identifies Subspecialty Differences in the Management of Pediatric Cataracts Associated with Uveitis. Ophthalmol Ther. 2020 Jun;9(2):293-303. doi: 10.1007/s40123-020-00245-x. Epub 2020 Mar 10.
- Background: PubMed 31788579Chen JL, Bhat P, Lobo-Chan AM. Perioperative Management of Uveitic Cataracts. Adv Ophthalmol Optom. 2019 Aug;4:325-339. doi: 10.1016/j.yaoo.2019.04.014. Epub 2019 May 18.
- Background: PubMed 30900580Yangzes S, Seth NG, Singh R, Gupta PC, Jinagal J, Pandav SS, Gupta V, Gupta A, Ram J. Long-term outcomes of cataract surgery in children with uveitis. Indian J Ophthalmol. 2019 Apr;67(4):490-495. doi: 10.4103/ijo.IJO_846_18.
- Background: PubMed 30574896Jinagal J, Gupta G, Agarwal A, Aggarwal K, Akella M, Gupta V, Suri D, Gupta A, Singh S, Ram J. Safety and efficacy of dexamethasone implant along with phacoemulsification and intraocular lens implantation in children with juvenile idiopathic arthritis associated uveitis. Indian J Ophthalmol. 2019 Jan;67(1):69-74. doi: 10.4103/ijo.IJO_713_18.
- Background: PubMed 30203671El Gharbawy SA, Darwish EA, Abu Eleinen KG, Osman MH. Efficacy of addition of nepafenac 0.1% to steroid eye drops in prevention of post-phaco macular edema in high-risk eyes. Eur J Ophthalmol. 2019 Jul;29(4):453-457. doi: 10.1177/1120672118799626. Epub 2018 Sep 11.
- Individual participant dataSharing planned: No
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.
Ashraf Khalaf Al Husseini, professor study director
Assiut University
Wael Mohammed Ahmed Soliman, professor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing cataract surgery in people with Cataract; Complicata, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mona Abdallah Abd AlRazik Ahmed, MD (01014398129, monaabdallah51290@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
final postoperative uncorrected visual acuity (UCVA) (time frame: 1 week post operative). 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?
On the ClinicalTrials.gov record for NCT04333069, which also lists 5 linked publications.
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 3 Apr 2020.