ISRCTN ISRCTN43189969
DOI https://doi.org/10.1186/ISRCTN43189969
Protocol serial number N0214181354
Sponsor Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder The Royal Wolverhampton Hospitals NHS Trust (UK), RWHT in kind contribution, NHS R&D Support Funding
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
12/05/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr B Ilango
Scientific

Wolverhampton Eye Infirmary
Cataract Surgery
Wolverhampton
WV10 0QP
United Kingdom

Email bilango@hotmail.com

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleCorneal protection after cataract surgery
Study objectivesWhat is the most comfortable and safest method for corneal protection after cataract surgery?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedEye diseases: cataract
InterventionEyepad vs eyeshield vs viscoelastic agent plus eyeshield in patients who have undergone cataract surgery.
Intervention typeOther
Primary outcome measure(s)

1. Pain scores on first postoperative day
2. Corneal fluorescein staining on first postoperative day

Key secondary outcome measure(s)

Patient mobility and satisfaction in the post-operative period

Completion date07/06/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration120
Key inclusion criteriaPatients who have undergone eye surgery, undergoing uncomplicated phacoemulsification under local anaesthesia
Key exclusion criteria1. Age < 18 years old
2. Difficulty in comprehension of study method or processes
3. Complicated cataract surgery
4. Pre-existing corneal disease
5. Corneal wound requiring suturing
6. Postoperative intraocular pressure of >25 mmHg
7. Greater than moderate anterior chamber reaction (+2 cells/flare) postoperatively
Date of first enrolment07/04/2006
Date of final enrolment07/06/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Wolverhampton Eye Infirmary
Wolverhampton
WV10 0QP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

12/05/2017: No publications found, verifying study status with principal investigator.